Sittings · Document

Draft report (COM(2025)0531 – C90424/2023 – 2025/0531(COD)) 2026-02-10

Amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products

Committee on the Environment, Climate and Food Safety Committee on the Internal Market and Consumer Protection

Amendment 441

Idoia Mendia, François Kalfon, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2, or as endocrine disruptor for human health of category 1 or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be available on the market for 12 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Justification

Permitting manufacturers to continue introducing new CMR-containing products into commerce after a substance receives CMR classification actively contradicts precaution by prioritizing commercial interests over protection from catastrophic health outcomes. While new placement must stop immediately, existing inventory requires a structured phase-out rather than instant removal. Most cosmetic products have shelf lives of 12-36 months but retail turnover of 2-4 months. Products remaining after 6 months represent slow-moving stock that would eventually require disposal anyway. A 12-month sales window provides ample time for normal inventory depletion through regular sales

Amendment 442

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be made available on the market for 6 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Justification

A limited transition period should be provided to economic operators after classification of CMR substances in existing cosmetic products to achieve their orderly withdrawal from the market. No new products should, however, be allowed on the market after the classification to prevent lock-ins and stranded investments and to protect citizens, including vulnerable groups.

Amendment 443

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation provided that a valid, and where necessary updated, Cosmetic Product Safety Report (CPSR) remains available. The Commission may, where necessary, extend the period referred to in the first subparagraph of this paragraph, in the Regulation amending the relevant Annexes to this Regulation, in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

Or. en

Justification

Under the CPR, the absence of formal transitional periods following a ban or restriction leads to the immediate withdrawal of products from the market, even where they are demonstrably safe, resulting in unnecessary waste and economic loss. The Omnibus proposal therefore rightly introduces transitional periods, which should be set at 24 months for placing on the market and 48 months for making available, provided a valid Cosmetic Product Safety Report (CPSR) exists. This allows reformulation without compromising safety, while urgent risks remain addressed through existing emergency procedures. Limited flexibility for longer periods in duly justified cases would further enhance legal certainty and prevent disruption.

Amendment 444

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Where a CMR substance of category 1A, 1B, or 2 or an endocrine disruptor for human health of category 1 or 2, classified under Part 3 of Annex VI to Regulation (EC) No 1272/2008, following a derogation request made in accordance with paragraph 1 or paragraph 2, second subparagraph, is prohibited or further restricted from use, cosmetic products containing that substance or not compliant with a restriction may continue to be made available on the market for 6 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Amendment 445

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation as long as a valid, and where needed updated, the cosmetic product safety report (CPSR) remains available.

Or. en

Justification

Many substances are restricted not cause SCCS has identified a safety concern but due to theoretical hazards or assumptions that alternatives exist. Those periods reflect realistic timeframe needed to identify alternatives, reformulate, and complete all assessments. Reformulation is a complex process requiring new safety assessment, updates to PIF packaging compatibility testing, re-notification in third-country markets. Shorter periods would lead to destruction of products raw materials and packaging causing financial losses and environmental waste.

Amendment 446

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’ as long as a valid, and where needed updated, cosmetic product safety report (CPSR) remains available.

Or. en

Amendment 447

Beatrice Timgren

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation as long as a valid, and where needed updated, cosmetic product safety report (CPSR) remains available.

Or. en

Amendment 448

Sigrid Friis, Gerben-Jan Gerbrandy

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Where a CMR substance or an endocrine disruptor for human health following a derogation request made in accordance with paragraph 1 or paragraph 2, second subparagraph, is prohibited or further restricted from use, cosmetic products containing that substance or not compliant with a restriction may continue to be made available on the Union market for 12 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.

Or. en

Justification

Cosmetic products are a major direct source of consumer exposure to endocrine disruptors including for children and other vulnerable groups. While the EU in recent years has restricted some potential endocrine disruptors, regulatory action has overall proven unreasonably slow and resource intensive. The endocrine disruptor butylparaben has for example been subject to regulatory scrutiny under EU cosmetics legislation for almost 20 years including as part of five safety assessments by the scientific committee. To achieve a simpler, faster approach, Article 15 should therefore be extended to endocrine disruptors. This will increase consumer protection against these harmful chemicals and reduce burdens on authorities while also enhancing legal signals to all market actors on the areas where innovation in safer alternatives should be prioritised. Likewise, a requirement to take account of potential health risks from combined exposures to multiple different substances should be introduced as foreseen in the Chemicals Strategy for Sustainability.

Amendment 449

Vytenis Povilas Andriukaitis

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Amendment 450

Raúl de la Hoz Quintano, Dolors Montserrat, Esther Herranz García, Susana Solís Pérez, Pablo Arias Echeverría

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Amendment 451

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci

Proposal for a regulation

Article 2 – paragraph 1 – point 2 – point b

Regulation (EC) No 1223/2009

Article 15 – paragraph 7

Text proposed by the Commission	Amendment
Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 12 months and be made available on the market for 24 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’	Cosmetic products containing a substance classified as a CMR substance of category 1A, 1B, or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 prohibited from use in cosmetic products or such substance not compliant with a restriction may continue to be placed on the market for 24 months and be made available on the market for 48 months after the entry into force of the relevant amendments to the relevant Annexes to this Regulation.’

Or. en

Amendment 452

Idoia Mendia, François Kalfon, Elisabeth Grossmann, Adnan Dibrani, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido

Proposal for a regulation

Article 2 – paragraph 1 – point 2 a (new)

Regulation (EC) No 1223/2009

Article 15a

Text proposed by the Commission	Amendment
	(2a) The following Article is inserted:
	Article 15a
	Per- and polyfluoroalkyl substances (PFAS)
	1. The use in cosmetic products of per- and polyfluoroalkyl substances (PFAS) shall be prohibited.
	2. Restrictions or prohibitions on the use of PFAS laid down in accordance with Regulation (EC) No 1907/2006 or (EU) 2019/1021 of the European Parliament and of the Council shall take precedence over paragraph 1.
	3. For the purpose of this Article, ‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).

Or. en

Justification

Use of PFAS in cosmetics—for water resistance, texture—is non-essential yet creates direct dermal exposure and environmental contamination through washing off. No safe exposure level exists for many PFAS. Cosmetic regulation must prohibit this entire chemical class to protect consumers and prevent irreversible environmental damage. PFAS has been banned in the recently revised Toy Safety Regulation.

Amendment 453

Idoia Mendia, Kristian Vigenin, François Kalfon, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido

Proposal for a regulation

Article 2 – paragraph 1 – point 2 b (new)

Regulation (EC) No 1223/2009

Article 16 – paragraphs 3 and 7

Text proposed by the Commission	Amendment
(3) In Article 16, paragraphs 3 and 7 are deleted;	(3) In Article 16, paragraph 3 is replaced by the following:
	"In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means prior to being placed on the market.
	The first subparagraph shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.
	The information notified to the Commission shall contain at least the following:
	(a)the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI;
	(b)the specification of the nanomaterial including size of particles, physical and chemical properties;
	(c)an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year;
	(d)the toxicological profile of the nanomaterial;
	(e)the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;
	(f)the reasonably foreseeable exposure conditions. The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof. The Commission shall provide a reference number for the submission of the toxicological profile, which may substitute the information to be notified under point (d)."

Or. en

(32009R1223)

Amendment 454

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EC) No 1223/2009

Article 16 – paragraphs 3 and 7

Text proposed by the Commission	Amendment
(3) In Article 16, paragraphs 3 and 7 are deleted;	deleted

Or. en

Amendment 455

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EC) No 1223/2009

Article 16 – paragraph 3

Text proposed by the Commission	Amendment
(3) In Article 16, paragraphs 3 and 7 are deleted;	(3) In Article 16, paragraph 3 is replaced by the following:
	'3. In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means prior to being placed on the market.
	The first subparagraph shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.
	The information notified to the Commission shall contain at least the following:
	(a) the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI;
	(b) the specification of the nanomaterial including size of particles, physical and chemical properties;
	(c) an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year;
	(d) the toxicological profile of the nanomaterial;
	(e) the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;
	(f) the reasonably foreseeable exposure conditions.
	The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof. The Commission shall provide a reference number for the submission of the toxicological profile, which may substitute the information to be notified under point (d).

Or. en

Justification

Nanomaterials in cosmetics raise special concerns with regard to their safety. As such, the presence of nanomaterials in cosmetics and corresponding hazard and exposure information should continue to be notified to the Commission before being placed on the market. This is necessary so that the Commission can request a safety assessment in case of concerns (see paragraph 4 of this Article). Without such notification, the information would not be available to the Commission, making it de facto very difficult if not impossible for them to ask for a safety assessment. The Commission should not be let off the hook with regard to its responsibility for the safety of nanomaterials, paragraph 4 of this Article should not be deprived of its "effet utile".The inclusion of relevant information in the cosmetic product safety report is not enough, as that report is not available to the Commission (only to the Member States). The Commission should not merely depend on information from a third party to request a safety evaluation (see paragraph 5 of this Article). The only modification that would be acceptable is that the notification no longer needs to be made six months before placing on the market. The empowerment of the Commission in Article 16 (7) to add further requirements should stay.

Amendment 456

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Regulation (EC) No 1223/2009

Article 16 – paragraph 3

Text proposed by the Commission	Amendment
(3) In Article 16, paragraphs 3 and 7 are deleted;	(3) In Article 16, paragraph 7 is deleted;

Or. en

Amendment 457

Proposal for a regulation

Article 2 – paragraph 1 – point -43 a (new)

Regulation (EC) No 1223/2009

Article 19 – paragraph 1 – point g a (new)

Present text	Amendment
	(-43 a) In Article 19(1), point (ga) is added is amended as follows:

Or. en

Amendment 458

Majdouline Sbai

Proposal for a regulation

Article 2 – paragraph 1 – point 3 a (new)

Regulation (EC) No 1223/2009

Article 16a (new)

Text proposed by the Commission	Amendment
	(3 a) The following Article is inserted:
	'Article 16a
	PFAS
	The use of per- and polyfluoroalkyl substances (PFAS) in cosmetic products shall be prohibited.'

Or. en

(Linked to the amendment of Article 5(5a) by the same author with regard to the date of application.)

Justification

PFAS are banned in France in cosmetics since January 2026. In 2025 the EU banned PFAS in toys. In 2024 the EU banned PFAS in food contact packaging. In 2023, four Member States and Norway proposed a universal restriction of PFAS, including for cosmetics. They made a clear case for prohibting PFAS in cosmetics. About 1% of cosmetic products contain PFAS. An analysis of the market share of PFAS-containing products showed that most occurred in the product category decorative cosmetics (3.7%), followed by skin care, hair care and toiletries (0.78, 0.65 and 0.27% respectively). There is sufficiently strong evidence that technically and economically feasible alternatives exist. There is no evidence of a shortage in supply of alternatives. The costs of a restriction within 18 months are assessed to be low. They proposed a restriction applicable within 18 months after entry into force.In October 2024, EVP Séjourné committed the following in his written responses to the European Parliament: "I will seek to ban the use of PFAS in consumer uses, like cosmetics, food contact materials and outdoor clothing." However, in the meantime, the Commission has made clear that it will not take any action until ECHA's scientific committees have given their opinion. Their opinions are expected for the end of 2026. So it will take at least until mid-2027 before the Commission will take any restrictive action against PFAS in cosmetics. Given the clear case for a restriction already made three years ago, we cannot afford to wait any longer. We should seize the opportunity of the chemical omnibus to also improve protection of human health and the environment. A ban of PFAS in cosmetics should be applicable within 18 months. As co-legislator we are entitled to adopt such a ban, there is no need to wait for ECHA's opinions as confirmed in the judgment by the ECJ in Case T 745/20.

Amendment 459

Proposal for a regulation

Article 2 – paragraph 1 – point 4 a (new)

Regulation (EC) No 1223/2009

Article 19 – paragraph 6 a (new)

Text proposed by the Commission	Amendment
	4a) In Article 19, paragraph 6a is added:
	‘6a. When cosmetic products are made available on the market through distance sales, the offer shall clearly and visibly indicate the information referred to in paragraph 1.’

Or. en

Justification

New obligation should be introduced to require online traders to clearly and visibly display the information required by Article 19 notably as regards responsible person contacts, CPNP number, and the ingredient list. This will likewise facilitate enforcement efforts against non-compliant products while also assisting consumers to avoid potentially dangerous products.

Amendment 460

Idoia Mendia, Kristian Vigenin, Elisabeth Grossmann, Adnan Dibrani, Sakis Arnaoutoglou, César Luena, Christophe Clergeau, Tiemo Wölken, Annalisa Corrado, Heléne Fritzon, Marta Temido, François Kalfon

Proposal for a regulation

Article 2 – paragraph 1 – point 7

Regulation (EC) No 1223/2009

Annex I

Text proposed by the Commission	Amendment
(7) Annex I is amended in accordance with Annex II to this Regulation;	deleted

Or. en

Amendment 461

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 2 – paragraph 1 – point 7

Regulation (EC) No 1223/2009

Annex I

Text proposed by the Commission	Amendment
(7) Annex I is amended in accordance with Annex II to this Regulation;	deleted

Or. en

Amendment 462

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 2 – paragraph 1 – point 7

Regulation (EC) No 1223/2009

Annex I

Text proposed by the Commission	Amendment
(7) Annex I is amended in accordance with Annex II to this Regulation;	deleted

Or. en

Amendment 463

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 1 – point -1 (new)

Regulation (EU) 2019/1009

Article 1 – paragraph 1 – point 1 – point b

Text proposed by the Commission	Amendment
	(-1) In article 1 , point 1, (b) of Regulation (EU) 2019/1009, is replaced by the following points:
	(b) plant protection products covered by the scope of Regulation (EC) No 1107/2009, including biological control products;
	(c) any organism placed on the market as a biostimulant that has been modified genetically which are subject to the requirements in place under Union legislation for genetically modified organisms;
	(d) Any organisms, species and essentially biological processes found in nature which are subject to the requirements under the biotech directive 98/44/EC and international conventions, laws and obligations. In line with those , they shall not be patented.

Or. en

Amendment 464

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2019/1009

Article 2 – paragraph 1 – point 15a

Text proposed by the Commission	Amendment
‘(15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’	‘(15a)‘digital contact’ means any up-to-date, free of charge, and accessible online communication channel, such as an email address or a contact form, through which economic operators can be contacted reached or engaged without the need to register, or to download or to use an application. Digital contact shall allow users and competent authorities to engage in a dialogue with the economic operators and exclude the use of automatic means or replies such as chatbots or automatic replies;’

Or. en

Amendment 465

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 3 – paragraph 1 – point 1 a (new)

Regulation (EU) 2019/1009

Article 1a (new)

Text proposed by the Commission	Amendment
	(1 a) The following Article is inserted:
	Article 1a
	Exclusion from patentability
	Processes that are essentially biological, as well as species or organisms, including micro-organisms, parts thereof, genetic information and the process features they contain shall not be patentable.
	This provision shall be applied in accordance with Directive 98/44/EC, and with relevant international conventions, laws, and obligations.

Or. en

Amendment 466

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2019/1009

Article 2 – paragraph 1 – point 15a

Text proposed by the Commission	Amendment
‘(15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’	‘(15a) ‘digital contact’ means any up-to-date and freely accessible online communication channel through which economic operators can be contacted without the need to register or to download an application or use additional applications specific to the economic operators;’

Or. en

Amendment 467

Daniel Buda

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2019/1009

Article 2 – paragraph 1 – point 15a

Text proposed by the Commission	Amendment
‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;	‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached directly, without the need for any intermediate step, such as registering any data or downloading an application;

Or. ro

Amendment 468

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2019/1009

Article 2 – paragraph 1 – point 15a

Text proposed by the Commission	Amendment
‘(15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’	‘(15a) ‘digital contact’ means any up-to-date, easily and freely accessible online communication channel through which a supplier can be contacted without the need to register or to download or use an application;’

Or. en

Amendment 469

Nikola Minchev

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2019/1009

Article 2 – paragraph 1 – point 15 a

Text proposed by the Commission	Amendment
‘(15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’	‘(15a) ‘digital contact’ means any up-to-date and freely accessible online communication channel through which economic operators can be reached without the need to register or to download an application;’

Or. en

Amendment 470

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Regulation (EU) 2019/1009

Article 2 – paragraph 1 – point 15a

Text proposed by the Commission	Amendment
‘(15a) ‘digital contact’ means any up-to-date and accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’	‘(15a) ‘digital contact’ means any up-to-date and freely accessible online communication channel through which economic operators can be reached or engaged without the need to register or to download an application;’

Or. en

Amendment 471

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point a – point ii

Regulation (EU) 2019/1009

Article 6 – paragraph 2 – subparagraph 2 a (new)

Text proposed by the Commission	Amendment
Manufacturers shall ensure that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be accessed.;	Manufacturers shall ensure that the EU fertilising product is accompanied by information on how the EU declaration of conformity can be obtained on request, for example by means of contact details, an internet address, a telephone number or a data carrier.

Or. nl

Amendment 472

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point b

Regulation (EU) 2019/1009

Article 6 – paragraph 3 – subparagraph 2

Text proposed by the Commission	Amendment
On request, manufacturers shall make the EU declaration of conformity available to other economic operators in electronic form.;	On request, manufacturers shall make the EU declaration of conformity available to other economic operators and other authorities in electronic form in a swift manner and without undue delay;

Or. en

Amendment 473

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point c

Regulation (EU) 2019/1009

Article 6 – paragraph 6 – subparagraph 1 – first and second sentences

Text proposed by the Commission	Amendment
Manufacturers shall indicate on the packaging of the EU fertilising product their name, registered trade name or registered trademark as well as their postal address and digital contact or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The postal address and digital contact shall indicate a single point through which the manufacturer can be reached.’	Manufacturers shall indicate on the packaging of the EU fertilising product their name, registered trade name or registered trademark as well as their postal address and digital contact or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The postal address and digital contact shall indicate a single point through which the manufacturer can be contacted in an effective and expeditious manner.’

Or. en

Amendment 474

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point d

Regulation (EU) 2019/1009

Article 6 – paragraph 9 – first sentence

Text proposed by the Commission	Amendment
Manufacturers shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority.’	Manufacturers shall, further to a reasoned request from competent authorities provide, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in an expeditious manner in the language which can be easily understood by authorities.’

Or. en

Amendment 475

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 2 – point d a (new)

Regulation (EU) 2019/1009

Article 6 – paragraph 9a (new)

Text proposed by the Commission	Amendment
	(d a) the following paragraph 9a is inserted:
	'9a. Where an EU fertilising product is subject to the requirement to have a Digital Product Passport in accordance with Regulation (EU) 2024/1781, the manufacturer may include the EU declaration of conformity in that Digital Product Passport. Such inclusion shall not alter the nature of the EU declaration of conformity as a document made available upon request to competent authorities and relevant economic operators.'

Or. en

Amendment 476

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point a

Regulation (EU) 2019/1009

Article 8 – paragraph 2 – subparagraph 1 – second sentence

Text proposed by the Commission	Amendment
They shall ensure that the manufacturer has drawn up the technical documentation, that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be accessed and, where appropriate, by other required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).	They shall ensure that the manufacturer has drawn up the technical documentation, that the EU fertilising product is accompanied by information on how the EU declaration of conformity can be obtained on request, for example by means of contact details, an internet address, a telephone number or a data carrier.

Or. nl

Amendment 477

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point c

Regulation (EU) 2019/1009

Article 8 – paragraph 8 – subparagraph 1

Text proposed by the Commission	Amendment
Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.	Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available in a swift manner and without undue delay to those authorities, upon request.

Or. en

Amendment 478

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point c

Regulation (EU) 2019/1009

Article 8 – paragraph 8 – subparagraph 2

Text proposed by the Commission	Amendment
On request, importers shall make the EU declaration of conformity available to other economic operators in electronic form.’	On request, importers shall make the EU declaration of conformity available to other economic operators and other authorities in electronic form in a swift manner and without undue delay.’

Or. en

Amendment 479

Proposal for a regulation

Article 3 – paragraph 1 – point 4 – point d

Regulation (EU) 2019/1009

Article 8 – paragraph 9 – first sentence

Text proposed by the Commission	Amendment
Importers shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation in a language which can be easily understood by that authority.’	Importers shall, further to a reasoned request from a competent authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation in a language which can be easily understood by authorities.’

Or. en

Amendment 480

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 5 – point a

Regulation (EU) No 2019/1009

Article 9 – paragraph 2 – subparagraph 1

Text proposed by the Commission	Amendment
Before making an EU fertilising product available on the market, distributors shall verify that it is accompanied by the internet address or data carrier through which the EU declaration of conformity can be accessed and, where appropriate, by other required documents, including the information referred to in Article 6(7) or Article 8(4) provided in the manner specified therein, in a language which can be easily understood by end-users in the Member State in which the EU fertilising product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.	Before making an EU fertilising product available on the market, distributors shall verify that it is accompanied by information on how the EU declaration of conformity can be obtained on request, for example by means of contact details, an internet address, a telephone number or a data carrier.

Or. nl

Amendment 481

Proposal for a regulation

Article 3 – paragraph 1 – point 5 – point b

Regulation (EU) 2019/1009

Article 9 – paragraph 5 – first sentence

Text proposed by the Commission	Amendment
Distributors shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation.’	Distributors shall, further to a reasoned request from a competent authority, provide it, in electronic form in a swift manner and without undue delay, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation.’

Or. en

Amendment 482

Proposal for a regulation

Article 3 – paragraph 1 – point 6 – point b

Regulation (EU) 2019/1009

Article 15 – paragraph 3

Text proposed by the Commission	Amendment
The manufacturer shall provide the notified body carrying out the conformity assessment procedure with all the information and documentation relating to conformity assessment procedures in electronic form.’	The manufacturer shall provide the notified body carrying out the conformity assessment procedure with all the information and documentation relating to conformity assessment procedures in electronic and in a machine-readable form in a swift manner and without undue delay.’

Or. en

Amendment 483

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Regulation (EU) No 2019/1009

Article 16 – paragraph 6

Text proposed by the Commission	Amendment
6. Where other Union legislation applicable to EU fertilising products requires the economic operator to include the information that the product complies with the requirements set out in that legislation in a digital product passport or to upload the EU declaration of conformity in a digital product passport, the information set out in Annex V to be included in the EU declaration of conformity and any digital labelling information in accordance with Article 11b, if applicable, shall be provided only in that digital product passport.	6. Where other Union legislation applicable to EU fertilising products requires the economic operator to include the information on how the EU declaration of conformity can be obtained on request, for example by means of contact details, an internet address, a telephone number or a data carrier.

Or. nl

Amendment 484

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b a (new)

Regulation (EU) 2019/1009

Article 42 – paragraph 4 b (new)

Text proposed by the Commission	Amendment
	(b a) the following paragraph 4b is inserted:
	'4b. The Commission shall, by [OP: 18 months after entry into force], assess whether the following materials meet the criteria for inclusion as component material categories in Annex II and, where appropriate, adopt delegated acts pursuant to paragraph 1 to amend Annex II:
	(a) coir pith that has undergone buffering treatment;
	(b) plant fibres and wood fibres produced using processes involving temperatures exceeding 100°C;
	(c) composted bark;
	(d) spent growing media derived from materials already compliant with Annex II.'

Or. en

Justification

Several critical and sustainable materials widely used in growing media remain outside the CMC framework: buffered coir (~10% global market), plant/wood fibres produced above 100°C (~5%), composted barks (~5-10%), and spent growing media

Amendment 485

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 9 b (new)

Regulation (EU) 2019/1009

New

Text proposed by the Commission	Amendment
	(9b) Regulation (EC) No 1069/2009 shall apply to animal by-products and derived products that may pose risks to public or animal health. If materials of animal origin fall outside the scope of that regulation it shall be because they are not considered to pose such risks. Where materials of animal origin are not subject to Regulation (EC) No 1069/2009, their suitability for use in EU fertilising products shall be assessed solely on the basis of the requirements of Regulation (EU) 2019/1009. The non-applicability of Regulation (EC) No 1069/2009 shall not in itself prevent such materials from being included in the relevant component material categories, provided that all applicable safety, quality and compliance assessment requirements under this Regulation are met.

Or. nl

Justification

Certain materials of animal origin used in fertilising products fall outside the scope of the regulation on animal by-products because they do not pose any risks to public or animal health. In practice, however, uncertainty remains as to their suitability in component material category 10, which leads to unnecessary regulatory barriers. This amendment clarifies the applicable legal framework, ensures consistency between the regulation on animal by-products and the regulation on fertilising products, and prevents the unintended exclusion of safe and established materials.

Amendment 486

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b b (new)

Regulation (EU) 2019/1009

Article 42 – paragraph 5a (new)

Text proposed by the Commission	Amendment
	bb) the following paragraph 5a is inserted:
	‘5a. For the purposes of this Regulation, products derived from animal by-products that are used solely as component materials in EU fertilising products may be made available on the market only where they originate from animal by-products or derived products that have reached an end point in the manufacturing chain in accordance with Article 5(2) of Regulation (EC) No 1069/2009. When determining such end points for derived products intended for use in EU fertilising products, the Commission shall ensure that: a) the processing and safety criteria, as well as any necessary risk-mitigation measures, are proportionate and specifically relevant to fertilising uses; b) those criteria and measures are appropriate to the risks arising from the application of fertilising products to soil; and c) those criteria and measures are aligned with the requirements set out in Article 42(5) of this Regulation. Where existing delegated or implementing acts adopted under Regulation (EC) No 1069/2009 do not meet those conditions, the Commission shall, where appropriate and in accordance with the procedures laid down in that Regulation, review and, where necessary, amend them to ensure such alignment.

Or. en

Amendment 487

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b c (new)

Regulation (EU) 2019/1009

Article 42 – paragraph 5 b (new)

Text proposed by the Commission	Amendment
	bc) the following paragraph 5b is inserted:
	5b. The Commission shall periodically examine whether the requirements governing the treatment of materials intended for use in fertilising products remain appropriate and, where necessary, adapt them in light of scientific and technical advances, national practices, and the aims of Regulation (EU) 2019/1009. This examination shall be carried out for the first time no later than two years after Regulation (EU) [Chemicals Omnibus VI] enters into force.

Or. en

Amendment 488

Sander Smit

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point -a (new)

Regulation (EU) 2019/1009

Article 42 – paragraph 1

Text proposed by the Commission	Amendment
	(-9a) in Article 42 (1), point (b) is replaced by the following:
	‘(b) amend Annex II to set out or modify:
	(i) component material categories;
	(ii) requirements applicable to one or more component material categories;
	(iii) for CMC 7, general safety and agronomic efficiency criteria for micro-organisms and a methodology for manufacturers to demonstrate compliance with those criteria and for notified bodies to confirm this assessment;'

Or. en

Justification

This provides the legal basis for the criteria-based pathway in Amendment 10. The Commission is empowered to establish general criteria through delegated acts, similar to the detergents approach. The current Article 42 mechanism requires Commission-led strain-by-strain assessment, which is incompatible with the pace of innovation in the plant biostimulant sector. No new micro-organisms have been added since FPR entry into force despite ongoing industry demand.

Amendment 489

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) 2019/1009

Article 42 – paragraph 4a – introductory part

Text proposed by the Commission	Amendment
‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:	‘4a. The Commission shall adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if the economic operators demonstrates compliance with those criteria in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products after verification and certification by a notified body. The criteria and methodology shall provide for verification and certification by a notified body that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:

Or. en

Amendment 490

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) 2019/1009

Article 42 – paragraph 4a – introductory part

Text proposed by the Commission	Amendment
‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:	‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if a manufacturer and the notified bodies thoroughly demonstrate and verify the compliance with those criteria in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The notified bodies shall invite other relevant national authorities, EFSA or JRC to provide input within a reasonable delay in order to contribute to a thorough verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:

Or. en

Amendment 491

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) 2019/1009

Article 42 – paragraph 4 – point a

Text proposed by the Commission	Amendment
‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:	‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if a manufacturer demonstrates the compliance with those criteria in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall define specific data protection disposals for test and study reports on micro-organisms and allow a notified body to verify that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:

Or. en

Amendment 492

Daniel Buda

Proposal for a regulation

Article 3 – paragraph 1 – point 9 – point b

Regulation (EU) 2019/1009

Article 42 – paragraph 4a – introductory part

Text proposed by the Commission	Amendment
‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:	‘4a. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to set out criteria and a methodology for the assessment of micro-organisms other than those listed in Annex II, which, if compliance with those criteria is demonstrated by the manufacturer in the conformity assessment of the EU fertilising product in accordance with that methodology, may be used as component material in EU fertilising products. The criteria and methodology shall allow for verification that the micro-organisms fulfil the criteria in paragraph 1, point (b), and provide, as a minimum, for the consideration of the following elements:

Or. ro

Amendment 493

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Regulation (EU) 2019/1009

Article 43

Text proposed by the Commission	Amendment
(10) Article 43 is deleted;	deleted

Or. en

Amendment 494

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Regulation (EU) 2019/1009

Article 43

Text proposed by the Commission	Amendment
(10) Article 43 is deleted;	(10) In Article 43, the following paragraph is added:
	‘By way of derogation from the first paragraph, the Commission is exceptionally allowed to amend several component material categories by one delegated act, in a timely manner and without undue delay, in the following cases:
	(a) to introduce or remove the same raw material; or
	(b) to introduce, amend or remove the same requirements.’

Or. en

Amendment 495

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 3 a (new)

Regulation (EC) No 1107/2009

Article 66 – paragraph 1

Text proposed by the Commission	Amendment
	Article 3a
	Amendments to Regulation (EC) 1107/2009
	Regulation (EC) 1107/2009 is amended as follows:
	In article 66, paragraph 1 is replaced by the following:
	1. Plant protection products which are not authorised shall not be advertised. Every advertisement for a plant protection product shall indicate the hazard pictograms and signal words, and be accompanied by the sentences ‘Use plant protection products safely. Always read the label and product information before use’. These words and sentences shall be easily legible and clearly distinguishable in relation to the whole advertisement. The words ‘plant protection products’ may be replaced by a more precise description of the product-type, such as fungicide, insecticide or herbicide.

Or. en

Amendment 496

Per Clausen, Anja Hazekamp

Proposal for a regulation

Article 3 b (new)

Regulation (EU) No 528/2012

Article 72 – paragraph 1

Text proposed by the Commission	Amendment
	Article 3b
	Amendments to Regulation (EU) No 528/2012
	Regulation (EU) No 528/20121 is amended as follows:
	In Article 72, the first paragraph is replaced by the following:
	1. Any advertisement for biocidal products shall, in addition to complying with Regulation (EC) No 1272/2008, indicate the hazard pictograms and signal words, and include the sentences ‘Use biocides safely. Always read the label and product information before use.’. These words and sentences shall be clearly distinguishable and legible in relation to the whole advertisement.

Or. en

Amendment 497

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 3

Text proposed by the Commission	Amendment
By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.	By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 47 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.

Or. en

Justification

Regulation (EU) 2025/2439 postpones several deadlines set out in Regulation (EU) 2024/2865 by one year. To ensure coherence within the CLP framework, the transitional deadlines laid down in Article 61(8) should be aligned accordingly. A uniform one-year adjustment would prevent conflicting timelines, enhance legal certainty, support simplification, and provide suppliers with sufficient time to adapt their classification, labelling and packaging processes.

Amendment 498

Aurelijus Veryga

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 3

Text proposed by the Commission	Amendment
By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.	By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 47 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.

Or. en

Amendment 499

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 3

Text proposed by the Commission	Amendment
By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.	By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 47 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.

Or. en

Amendment 500

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 3

Text proposed by the Commission	Amendment
By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.	By way of derogation from Article 17(1), Article 25(6) of Regulation (EC) No 1272/2008, section 1.5.1.2 and section 1.6 of Annex I to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date of the day before the date of entry into force of this Regulation], substances and mixtures may until [OP: please insert the date of the last day of the month following 23 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, points (2) and (3) of this Regulation and points (3) and (8) of Annex I to this Regulation.

Or. en

Amendment 501

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission	Amendment
2. Points (4) to (7) of Annex I shall apply from 1 July 2026.	2. Points (4) to (7) of Annex I shall apply from 1 July 2027.

Or. en

Justification

Regulation (EU) 2025/2439 postpones several application dates in Regulation (EU) 2024/2865 by one year. To ensure coherence across the CLP framework, the transitional deadlines in Article 61(8) should be aligned accordingly. A uniform one-year shift avoids conflicting timelines, enhances legal certainty and simplification, and gives suppliers sufficient time to adapt classification, labelling and packaging processes across the internal market.

Amendment 502

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission	Amendment
2. Points (4) to (7) of Annex I shall apply from 1 July 2026.	2. Points (4) to (7) of Annex I shall apply from 1 July 2027.

Or. en

Amendment 503

Aurelijus Veryga

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission	Amendment
2. Points (4) to (7) of Annex I shall apply from 1 July 2026.	2. Points (4) to (7) of Annex I shall apply from 1 July 2027.

Or. en

Amendment 504

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission	Amendment
3. Article 1, points (5) to (8) and points (1), (2) and (9) of Annex I shall apply from 1 January 2028.	3. Article 1, points (5) to (8) and points (1), (2) and (9) of Annex I shall apply from 1 January 2029.

Or. en

Justification

Regulation (EU) 2025/2439 postpones several application dates and transitional provisions in Regulation (EU) 2024/2865 by one year. To ensure coherence across the CLP framework, the transitional deadlines in Article 61(8) should be aligned accordingly. A uniform one-year shift avoids conflicting timelines, enhances legal certainty and simplification, and gives suppliers sufficient time to adapt classification, labelling and packaging processes.

Amendment 505

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission	Amendment
3. Article 1, points (5) to (8) and points (1), (2) and (9) of Annex I shall apply from 1 January 2028.	3. Article 1, points (5) to (8) and points (1), (2) and (9) of Annex I shall apply from 1 January 2029.

Or. en

Amendment 506

Aurelijus Veryga

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission	Amendment
3. Article 1, points (5) to (8) and points (1), (2) and (9) of Annex I shall apply from 1 January 2028.	3. Article 1, points (5) to (8) and points (1), (2) and (9) of Annex I shall apply from 1 January 2029.

Or. en

Amendment 507

Aurelijus Veryga

Proposal for a regulation

Article 5 – paragraph 4

Text proposed by the Commission	Amendment
4. Article 1, points (1), (2) and (3), points (3) and (8) of Annex I shall apply from [OP: please insert the date of 36 months after the entry into force of this Regulation)]	4. Article 1, points (1), (2) and (3), points (3) and (8) of Annex I shall apply from [OP: please insert the date of 48 months after the entry into force of this Regulation)]

Or. en

Amendment 508

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Article 5 – paragraph 4

Text proposed by the Commission	Amendment
4. Article 1, points (1), (2) and (3), points (3) and (8) of Annex I shall apply from [OP: please insert the date of 36 months after the entry into force of this Regulation)]	4. Article 1, points (1), (2) and (3), points (3) and (8) of Annex I shall apply from [OP: please insert the date of 48 months after the entry into force of this Regulation)]

Or. en

Amendment 509

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Article 5 – paragraph 4

Text proposed by the Commission	Amendment
4. Article 1, points (1), (2) and (3), points (3) and (8) of Annex I shall apply from [OP: please insert the date of 36 months after the entry into force of this Regulation)]	4. Article 1, points (1), (2) and (3), points (3) and (8) of Annex I shall apply from [OP: please insert the date of 48 months after the entry into force of this Regulation)]

Or. en

Justification

This amendment is to align the application dates of Article 1, points (1), (2) and (3), points (3) and (8) of Annex I to the updated Article 61(9).

Amendment 510

Majdouline Sbai

Proposal for a regulation

Article 5 – paragraph 5

Text proposed by the Commission	Amendment
5. Article 2, point (1) to (8) shall apply from [OP: please insert the date of entry into force of this Regulation)]	5. Article 2, point (1) to (3) and (4) to (8) shall apply from [OP: please insert the date of entry into force of this Regulation)]

Or. en

Justification

Editorial change in light of the amendment by the same author with regard to a new point (3a) of Article 2.

Amendment 511

Majdouline Sbai

Proposal for a regulation

Article 5 – paragraph 5 a (new)

Text proposed by the Commission	Amendment
	5 a. Article 2, point (3a) shall apply from [OP: please insert the date of 18 months after entry into force of this Regulation]

Or. en

Justification

The ban of PFAS should apply within 18 months, as proposed by the dossier submitters in the context of the universal PFAS restriction.

Amendment 512

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex I – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.4

Text proposed by the Commission	Amendment
(1) in Annex I, section 1.2.1.4 is replaced by the following:	deleted
‘1.2.1.4.
The dimensions of the label and of each pictogram shall be as follows:
Table 1.3
Minimum dimensions of labels and pictograms
[...]
’;’

Or. en

Amendment 513

Proposal for a regulation

Annex I – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.4 – introductory part

Text proposed by the Commission	Amendment
‘1.2.1.4 The dimensions of the label and of each pictogram shall be as follows:	‘1.2.1.4 The dimensions of the label and of each pictogram, and the font size of letters shall be as follows:

Or. en

Amendment 514

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Annex I – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.4. – introductory part

Text proposed by the Commission	Amendment
The dimensions of the label and of each pictogram shall be as follows:	The dimensions of the label and of each pictogram, and the font size letters shall be as follows:

Or. en

Amendment 515

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione

Proposal for a regulation

Annex I – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.4. - Table 1.3 - title

Text proposed by the Commission	Amendment
Minimum dimensions of labels and pictograms	Minimum dimensions of labels and pictograms for substances and mixtures available in the course of industrial or professional activities in direct business to business operations:

Or. en

Justification

Linked to following changes, where it is suggested to distinguish between B2B (with flexible rules on font sizes) and B2C.

Amendment 516

Proposal for a regulation

Annex I – paragraph 1 – point 1

Regulation (EC) No 1272/2008

Annex I – Section 1.2.1.4 – Table 1.3 – title

Text proposed by the Commission	Amendment
Minimum dimensions of labels and pictograms	Minimum dimensions of labels and pictograms and minimum font size

Or. en

Amendment 517

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	deleted

Or. en

Amendment 518

Martin Hojsík, Michal Wiezik, Pascal Canfin, Grégory Allione, Yvan Verougstraete

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5.

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following;
	1.2.1.5 The text on the label of substances and mixtures available to general public shall have the following characteristics:
	(a) printed in black on a white background;
	(b) the distance between two lines shall be at least 120 % of the font size;
	(c) a single font that is easily legible and without serifs shall be used;
	(d) the letter spacing shall be appropriate for the selected font to be easily legible.
	For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains easily legible, where it is deemed important to place the most critical statement, such as a hazard statement or EUH statement, and where the outer packaging meets the requirements of Article 17.
	The text on the label of products available in the course of industrial or professional activities in direct business to business operations:
	The text on the label shall be legible. Legibility means the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.
	It shall have at least the following characteristics:
	(a) printed in a contrasting colour compared to the background;
	(b) a single typeface that is easily legible and without serifs shall be used;
	(c) the letter spacing shall be appropriate for the selected typeface to be easily legible;
	(d) the line spacing shall be appropriate for the selected typeface to be easily readable and to ensure that lines of text do not overlap;
	(e) an appropriate font size with regard to the size of the label and the required label elements.

Or. en

Justification

The European Commission deletes clear formatting rules that are needed to ensure enforceability of rules. Therefore, this amendment bring the rules back into CLP, however gives flexibility from the rules to labelling of chemicals in course of commercial activities in direct business to business sales.

Amendment 519

Majdouline Sbai

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following:
	1.2.1.5 The text on the label shall be legible. Legibility means the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background. It shall have at least the following characteristics:
	(a) printed in a contrasting colour compared to the background;
	(b) a single typeface that is easily legible and without serifs shall be used;
	(c) the distance between two lines shall be at least 120% of the font size;
	(d) the letter spacing shall be appropriate for the selected typeface to be easily legible.
	(f) an appropriate font size with regard to the size of the label and the required label elements.
	For substances or mixtures made available on the market for the general public, the label elements referred to in Article 17(1) shall use a font size where the x-height is equal to or greater than 1,2 mm. In case of packaging or containers for the general public the largest surface of which has an area of less than 80 cm2 , the x-height of the font size referred to in paragraph 2 shall be equal to or greater than 0,9 mm.

Or. en

Justification

A basic requirement of good readability is line spacing. Unfortunately, proper line spacing is not always respected. For that reason, the recently revised CLP Regulation introduced the generic requirement of 120% line spacing in all cases. This should be maintained. When it comes to font sizes, it is important to distinguish between B2B and B2C. While relevant arguments have been put forward that flexibility is needed for B2B labelling, not least in light of the availability of material safety data sheets for business operators, minimum font size should clearly be established for products for sale to the general public to ensure proper readability of hazard information. It is of paramount importance to ensure that consumer are properly informed of the hazards of a substance or a mixture. That requires that the obligation of minimum font size as established in the latest revision is retained for B2C. A minimum font size with an x-height of 1,2 mm is required for food labelling pursuant to Regulation (EU) No 1169/2011 on the provision of food information to consumers. This is the bare minimum and should obviously also be established in case of hazardous substances or mixtures. In analogy to that Regulation, a smaller minimum font size would be allowed for small packaging.

Amendment 520

Nikola Minchev

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following:
	1.2.1.5 The text on the label shall be legible. Legibility means the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.
	The label shall have all of the following characteristics to ensure it is easily readable:
	a) clear contrast between the text of the label and the background;
	b) an appropriate font size with regard to the size of the label;
	c) an appropriate letter spacing;
	d) an appropriate line spacing, ensuring that lines do not overlap;

Or. en

Amendment 521

Anne-Sophie Frigout, Mathilde Androuët, Silvia Sardone, Marie-Luce Brasier-Clain, Valérie Deloge, Antonín Staněk, Virginie Joron

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following:
	1.2.1.5 The text on the label must be legible. Legibility shall be assessed on the basis of the overall clarity of the information, taking into account, in particular, the size of the characters, the contrast with the background and the material characteristics of the packaging. This requirement shall be assessed in a proportionate and pragmatic manner, taking full account of the physical and technical constraints of the packaging, its dimensions and the intended user of the product.

Or. fr

Amendment 522

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following:
	1.2.1.5 The text on the label shall be legible. Legibility means the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.

Or. en

Amendment 523

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following; 1.2.1.5 The text on the label shall be legible. Legibility means the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.

Or. en

Justification

This amendment clarifies the factors determining label legibility, which is essential as consumers often rely solely on labels for hazard information. Specifying elements such as contrast, typeface, spacing, material and layout supports effective hazard communication without imposing unnecessary constraints on professional-use products. References to ECHA guidance are unnecessary, as label-formatting tasks are already covered by Article 50(2) of Regulation (EC) No 1272/2008.

Amendment 524

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008

Annex I – section 1.2.1.5

Text proposed by the Commission	Amendment
(2) in Annex I, section 1.2.1.5 is deleted;	(2) in Annex I, section 1.2.1.5 is replaced by the following; 1.2.1.5 The text on the label shall be legible. Legibility means the physical appearance of information, by means of which the information is visually accessible and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.

Or. en

Amendment 525

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – Section 1.5.1.2

Text proposed by the Commission	Amendment
1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;	1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture and the telephone number. ;

Or. en

Amendment 526

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – section 1.5.1.2

Text proposed by the Commission	Amendment
1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;	1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name, telephone number and/or digital contact of the suppliers of the substance or mixture.;

Or. en

Amendment 527

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – section 1.5.1.2

Text proposed by the Commission	Amendment
1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;	1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact or telephone number of the suppliers of the substance or mixture.;

Or. en

Amendment 528

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – section 1.5.1.2

Text proposed by the Commission	Amendment
1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;	1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, the name, telephone number or digital contact of the suppliers of the substance or mixture.’;

Or. en

Amendment 529

Aurelijus Veryga

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – section 1.5.1.2

Text proposed by the Commission	Amendment
1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;	1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, the name, telephone number or digital contact of the suppliers of the substance or mixture.’;

Or. en

Amendment 530

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008

Annex I – section 1.5.1.2

Text proposed by the Commission	Amendment
1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and digital contact of the suppliers of the substance or mixture.;	1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, the name, telephone number or digital contact of the suppliers of the substance or mixture;

Or. en

Justification

This amendment improves coherence between CLP and the revised Detergents and Surfactants Regulation, which requires a telephone number on labels. Allowing the supplier’s name with either a telephone number or a digital contact on inner packaging aligns EU rules, supports uniform compliance, and ensures proportionate contact information for space-constrained packaging. Removing the signal word is justified, as the hazard pictogram already clearly indicates danger without reducing protection.

Amendment 531

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 4

Regulations (EC) No 1272/2008

Annex I – section 1.5.2.4 – heading

Text proposed by the Commission	Amendment
1.5.2.4. Labelling of packages where the contents do not exceed 10 ml ;	1.5.2.4. Labelling of packages where the contents do not exceed 100 ml ;

Or. en

Amendment 532

Aurelijus Veryga

Proposal for a regulation

Annex I – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4 – heading

Text proposed by the Commission	Amendment
1.5.2.4. Labelling of packages where the contents do not exceed 10 ml ;	1.5.2.4. Labelling of packages where the contents do not exceed 75 ml ’;

Or. en

Amendment 533

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 4

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4 – heading

Text proposed by the Commission	Amendment
1.5.2.4. Labelling of packages where the contents do not exceed 10 ml ;	1.5.2.4. Labelling of packages where the contents do not exceed 75 ml ;

Or. en

Justification

To align with the proposed Article 29(2), the amendment establishes a specific regime for packaging of up to 75 ml, permitting a reduced set of label elements in accordance with Annex I, section 1.5.2.4. This approach ensures a proportionate and practical solution for small packaging, where space limitations make full labelling challenging, while continuing to ensure safety and regulatory compliance.

Amendment 534

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – introductory part

Text proposed by the Commission	Amendment
1.5.2.4.1. The label elements set out in Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml, the outer packaging meets the requirements set out in Article 17(1) and any of the following applies:	1.5.2.4.1. The label elements set out in Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 100 ml, the outer packaging meets the requirements set out in Article 17(1) and any of the following applies:

Or. en

Amendment 535

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – introductory part

Text proposed by the Commission	Amendment
1.5.2.4.1. The label elements set out in Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml, the outer packaging meets the requirements set out in Article 17(1) and any of the following applies:	1.5.2.4.1. The label elements set out in Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 75 ml, the outer packaging meets the requirements set out in Article 17(1) and any of the following applies:

Or. en

Justification

The amendment introduces a targeted derogation for inner containers up to 75 ml where all Article 17(1) CLP label elements appear on the outer packaging. It addresses space and multilingual constraints without compromising safety, as full hazard information remains available at point of sale and use. Compared with a 10 ml limit, 75 ml better reflects common small formats, providing practical relief for SMEs while maintaining a high level of protection.

Amendment 536

Aurelijus Veryga

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – introductory wording

Text proposed by the Commission	Amendment
1.5.2.4.1. The label elements set out in Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml, the outer packaging meets the requirements set out in Article 17(1) and any of the following applies:	1.5.2.4.1. The label elements set out in Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 75 ml, the outer packaging meets the requirements set out in Article 17(1) and any of the following applies:

Or. en

Amendment 537

Christian Doleschal

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – point b

Text proposed by the Commission	Amendment
(b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II, and is not classified in any of the following hazard classes and categories:	(b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:

Or. en

Amendment 538

Majdouline Sbai

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – point b

Text proposed by the Commission	Amendment
(b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II, and is not classified in any of the following hazard classes and categories:	(b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:

Or. en

(Linked to the amendment of point b - new point (fa) of this section by the same author.)

Justification

Amendment 539

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – point b

Text proposed by the Commission	Amendment
(b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II, and is not classified in any of the following hazard classes and categories:	(b) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II, and is not classified in any of the following hazard classes and categories:

Or. en

Amendment 540

Christian Doleschal

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – point d

Text proposed by the Commission	Amendment
(d) skin corrosion, category 1, any sub-category;	deleted

Or. en

Amendment 541

Christian Doleschal

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – point )

Text proposed by the Commission	Amendment
(e) serious eye damage, category 1;	deleted

Or. en

Amendment 542

Majdouline Sbai

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.1 – point b – point fa new

Text proposed by the Commission	Amendment
	(f a) skin sensitisation, any category;

Or. en

(Linked to the amendment of point b of this section by the same author.)

Justification

Skin sensitisation is a serious health hazard. The corresponding label requirement EUH 208 "Contains (name of sensitising substance). May produce an allergic reaction" should not be allowed to be omitted from the inner packaging of small packages. To ensure this, it is not enough to delete the reference to section 2.8 of Part 2 of Annex II as done also by Council, but to also add this category to the list of hazard classes that do not qualify for this exemption.

Amendment 543

Christian Doleschal

Proposal for a regulation

Annex I – paragraph 1 – point 5

Regulation (EC) No 1272/2008

Annex I - section 1.5.2.4.1 - point g

Text proposed by the Commission	Amendment
(g) aspiration hazard;	deleted

Or. en

Amendment 544

Silvia Sardone, Ondřej Knotek, Jana Nagyová, Roberto Vannacci, Anne-Sophie Frigout, Mathilde Androuët, Valérie Deloge

Proposal for a regulation

Annex I – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.3 – point a

Text proposed by the Commission	Amendment
(a) the contents of the package do not exceed 10 ml;	(a) the contents of the package do not exceed 100 ml;

Or. en

Amendment 545

Aurelijus Veryga

Proposal for a regulation

Annex I – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.3 – point a

Text proposed by the Commission	Amendment
(a) the contents of the package do not exceed 10 ml;	(a) the contents of the package do not exceed 75 ml;

Or. en

Amendment 546

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.3. – point a

Text proposed by the Commission	Amendment
(a) the contents of the package do not exceed 10 ml;	(a) the contents of the package do not exceed 75 ml;

Or. en

Justification

Alignment with proposed Article 29(2): the amendment allows reduced label elements for packaging up to 75 ml in line with Annex I, section 1.5.2.4. This ensures proportionality and practicality for small packaging with space constraints, while maintaining safety and compliance.

Amendment 547

Proposal for a regulation

Annex I – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Annex I – Section 1.5.2.4.3 – point b

Text proposed by the Commission	Amendment
(b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II;	(b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II;

Or. en

Amendment 548

Majdouline Sbai

Proposal for a regulation

Annex I – paragraph 1 – point 7

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.3 – point b

Text proposed by the Commission	Amendment
(b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II, except for section 2.8 of Part 2 of Annex II;	(b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II;

Or. en

Justification

Amendment 549

Majdouline Sbai

Proposal for a regulation

Annex I – paragraph 1 – point 7 a (new)

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.4.3a (new)

Text proposed by the Commission	Amendment
	(7 a) in Annex I, section 1.5.2.4.3a is added:
	'1.5.4.3a Where section 1.5.2.4.3 applies, the label on the packaging shall contain the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and, where applicable, the hazard pictograms ‘GHS01’ or ‘GHS05’;’

Or. en

Justification

The hazard pictograms for explosive substances (GHS01) and for corrosive substances (GHS05), when applicable, shall always be on the label, also for small packaging.

Amendment 550

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 7 a (new)

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.5a

Text proposed by the Commission	Amendment
	(7 a) In Annex I, section 1.5.2.5a is added:
	1.5.2.5a Labelling of technical containers that operate as an integral part of a system of equipment where the contents do not exceed 150 ml.
	The label elements required by Article 17 may be reduced in accordance with 1.5.2.5a.2 and 1.5.2.5a.3 where:
	(a) the contents of the inner packaging do not exceed 150 ml
	(b) full hazard label information is provided on the outer packaging
	(c) full hazard label information is provided accompanied by instructions for keeping it with the equipment; and
	(d) the inner packaging is a replaceable unit that contains substances or mixtures and releases them in a controlled fashion when operating as part of a system of equipment and that must be inserted into system equipment during operation of the system.

Or. en

Justification

The proposed derogation would apply to technical containers integrated into equipment, such as inkjet cartridges under 150 ml, where full CLP hazard information is provided on the outer packaging. Because cartridges and printers are designed as one system, label space on cartridges is very limited and fold-out labels cannot be used without affecting installation or function. As a result, CLP offers no practical multilingual labeling solution for cartridges.

Amendment 551

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 7 b (new)

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.5ab

Text proposed by the Commission	Amendment
	(7 b) In Annex I, section 1.5.2.5ab is added:
	1.5.2.5ab Where section 1.5.2.5a applies the label on the inner packaging and any intermediate packaging shall contain at least:
	(a) the product identifier in accordance with Article 18(2) for substances and Article 18(3) point (a) for mixtures;
	(b) where applicable the pictogram;
	(c) where applicable the unique formula identifier;
	(d) name, registered name or trademark of the supplier; and
	(e) telephone number or digital contact.

Or. en

Justification

Amendment 552

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 7 c (new)

Regulation (EC) No 1272/2008

Annex I – section 1.5.2.5ac

Text proposed by the Commission	Amendment
	(7 c) In Annex I, section 1.5.2.5ac is added:
	1.5.2.5ac: Where 1.5.2.5a applies and the contents of the inner packaging do not exceed 30 ml the information required by 1.5.2.5a may be further reduced so that the label on the inner packaging and any intermediate packaging shall contain at least:
	(a) the product identifier in accordance with Article 18(2) for substances and Article 18(3) point (a) for mixtures; and
	(b) where applicable the following pictograms: GHS01, GHS05, GHS06, GHS08.
	Where more than two pictograms are assigned GHS06 and GHS08 may take precedence over GHS01 and GHS05. Where this exemption applies the pictograms may be reduced to 5 mm x 5 mm.

Or. en

Justification

Amendment 553

Proposal for a regulation

Annex I – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Annex I – section 1.6 – point b a new

Text proposed by the Commission	Amendment
	(b a) The telephone number for the supplier(s) required according to Article 17(1), point (a), and where relevant the third subparagraph of Article 25(6) and section 1.5.1.2 of Annex I’;

Or. en

Amendment 554

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex I – paragraph 1 – point 8

Regulation (EC) No 1272/2008

Annex I – section 1.6 – point b a (new)

Text proposed by the Commission	Amendment
	(b a) information not directly related to the classification and labelling of hazards, including in particular instructions for use, recommended application rates, storage conditions, and other information related to the proper use of the product.

Or. en

Justification

This amendment broadens the information that may be provided on a digital label under Annex I, Section 1.6 of Regulation (EC) No 1272/2008. Allowing non-hazard information, such as instructions for use, application rates and storage conditions, to be provided digitally reduces pressure on space-constrained physical labels, improves readability, supports multilingual requirements and avoids unnecessary packaging expansion, while ensuring that all hazard information remains on the physical label.

Amendment 555

Proposal for a regulation

Annex I – paragraph 1 – point 9

Regulation (EC) No 1272/2008

Annex II – part 5 – point b

Text proposed by the Commission	Amendment
(b) For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the copy of the label elements referred to in Article 17, points (c) to (h) shall be provided on a visible place on the respective pump. The unique formula identifier referred to in Article 25(7) does not need to be provided.	(b) For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the copy of the label elements referred to in Article 17, points (c) to (h) shall be provided on a visible place on the respective pump.

Or. en

Amendment 556

Proposal for a regulation

Annex I – paragraph 1 – point 9

Regulation (EC) No 1272/2008

Annex II – part 5 – point c

Text proposed by the Commission	Amendment
(c) When a vehicle fuel is supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a copy of the label elements referred to in Article 17, points (c) to (h), shall be provided to be attached to the receptacle, unless the receptacle is already appropriately labelled. The unique formula identifier referred to in Article 25(7) does not need to be provided..	(c) When a vehicle fuel is supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a physical copy of the label elements referred to in Article 17, points (c) to (h), shall, in addition to the visible place on the pump, also be provided to be attached to the receptacle.

Or. en

Amendment 557

Christian Doleschal

Proposal for a regulation

Annex I a (new)

Regulation (EC) No 1272/2008

Text proposed by the Commission	Amendment
	Section 1.5.2.4 shall not apply to substances or mixtures within the scope of Regulation (EC) No 1107/2009 or biocidal products within the scope of Regulation (EU) No 528/2012.

Or. en

Amendment 558

Proposal for a regulation

Annex II

Regulation (EC) No 1223/2009

Annex I – Part A – point 2

Text proposed by the Commission	Amendment
In Annex I to Regulation (EC) No 1223/2009 Part A, point 2 is replaced by the following:	deleted
‘2.Physical/chemical characteristics and stability of the cosmetic product
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.
The stability of the cosmetics product under reasonably foreseeable storage conditions.
The specification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the preamble to Annexes II to VI, size of particles, physical and chemical properties.
The safety data of the nanomaterial (including its toxicological profile and exposure conditions) relating to the category of cosmetic product, as used in such products.’

Or. en

Amendment 559

Pietro Fiocchi, Antonella Sberna

Proposal for a regulation

Annex II

Regulation (EC) No 1223/2009

Annex II – Part A – point 2

Text proposed by the Commission	Amendment
In Annex I to Regulation (EC) No 1223/2009 Part A, point 2 is replaced by the following:	deleted
‘2. Physical/chemical characteristics and stability of the cosmetic product
The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.
The stability of the cosmetics product under reasonably foreseeable storage conditions.
The specification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the preamble to Annexes II to VI, size of particles, physical and chemical properties.
The safety data of the nanomaterial (including its toxicological profile and exposure conditions) relating to the category of cosmetic product, as used in such products.’

Or. en

Justification

The proposal to introduce specific nanomaterial requirements in Annex I, Part A, point 2 of the CPR would create unnecessary duplication and additional administrative burden. The same information is already required under existing provisions, in particular Article 13 and other relevant parts of Annex I of the Cosmetic Product Safety Report (CPSR). Removing these provisions would avoid redundant documentation and reduce costs without compromising safety, as robust mechanisms for the assessment of nanomaterials remain in place elsewhere in the CPR.

Amendment 560

Majdouline Sbai

Proposal for a regulation

Annex II – paragraph 1

Regulation (EC) No 1223/2009

Annex I – Part A – point 2 – third subparagraph

Text proposed by the Commission	Amendment
The specification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the preamble to Annexes II to VI, size of particles, physical and chemical properties.	The specification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the preamble to Annexes II to VI, size of particles, physical and chemical properties, as well as an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year.

Or. en

Justification

The requirements as laid down in Article 16(3) of the current Cosmetic Products Regulation with regard to the notification of nanomaterials should also be included in the chemical product safety report.

Amendment 561

Majdouline Sbai

Proposal for a regulation

Annex II – paragraph 1

Regulation (EC) No 1223/2009

Annex I – Part A – point 2 – fourth subparagraph

Text proposed by the Commission	Amendment
The safety data of the nanomaterial (including its toxicological profile and exposure conditions) relating to the category of cosmetic product, as used in such products.	The safety data of the nanomaterial (including its toxicological profile and reasonably foreseeable exposure conditions) relating to the category of cosmetic product, as used in such products.

Or. en

Justification

Alignment with the current provisions, e.g. Article 13(1)(f)(ii), which speaks about "reasonably foreseeable exposure conditions", and not just "exposure conditions".

Amendment 562

Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Adam Jarubas, Hanna Gronkiewicz-Waltz

Proposal for a regulation

Annex III – paragraph 1 – point -1 (new)

Regulation (EC) No 1223/2009

Preamble to the Annexes II to VI – point 1 – point a and b

Present text	Amendment
	(-1) in the preamble to Annexes II to VI, point 1, point a and b are replaced by the following:
	"(a) ‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, nails, the hair or the mucous membranes;
	(b) ‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, nails, the hair or the mucous membranes;"

Or. en

Justification

Preamble defines “rinse-off” and “leave-on” products by reference to cosmetic products applied to skin, hair or mucous membranes, without explicitly covering products intended for application on nails. Although nail products fall under the def. of cosmetic product in Article 2, lack of explicit reference to nails creates legal uncertainty where obligations depend on exposure assumptions. For legal clarity and consistent application of Regulation, products intended for nails should be explicitly included in these definitions, based on conditions of use and contact duration.

Amendment 563

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point -1 (new)

Regulation (EU) 2019/1009

Annex I – Part II - PFC 4

Text proposed by the Commission	Amendment
	(-1) In Annex I, Part II, PFC 4, the following point 1a is inserted:'
	1a. A growing medium may contain, in addition to component materials listed in Annex II:
	(a) EU fertilising products belonging to PFC 1 (fertiliser) for the purpose of adjusting the nutrient content;
	(b) EU fertilising products belonging to PFC 2 (liming material) for the purpose of adjusting the pH value;
	(c) EU fertilising products belonging to PFC 5 (inhibitor) incorporated within a component EU fertilising product referred to in points (a) or (b).
	The inclusion of such EU fertilising products shall not result in the growing medium being classified as a blend under PFC 7, provided that the total quantity of added EU fertilising products does not exceed 15% by weight of the final product.'

Or. en

Justification

Annex III, Part III sets ±5% relative deviation tolerance for PFC 4 by volume. A negative deviation limit protects consumers, but penalising positive deviation (giving more than declared) is unnecessary and disproportionate

Amendment 564

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point -1 (new)

Regulation (EU) 2019/1009

Annex I – Part II – point 6

Text proposed by the Commission	Amendment
	(-1) In Annex I, Part II, point 6 is replaced by the following:
	6. An EU fertilising product shall not contain phosphonates, with the exception of:(a) inorganic phosphite salts used in EU fertilising products belonging to PFC 6 (plant biostimulant), where the manufacturer demonstrates the agronomic benefit of phosphite for the intended biostimulant function and compliance with residue limits established for plant protection products containing fosetyl.'

Or. en

Justification

The current blanket ban on phosphonates treats all forms the same, despite organic and inorganic forms having very different properties, uses, and safety profiles. Phosphite-based plant biostimulants have demonstrated agronomic benefits (improving nutrient uptake, stress tolerance) but are blocked from the EU market. Allowing inorganic phosphite in biostimulants under controlled conditions, with reference to existing residue frameworks, enables innovation while maintaining safety standards.

Amendment 565

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 1 a (new)

(EU) 2019/1009

Annex I

Text proposed by the Commission	Amendment
	(1 a) in Annex I, Part II, PFC 4, point 2, the row for "Hexavalent chromium (Cr VI)" is deleted.

Or. en

Justification

Chromium VI is not naturally occurring in growing media raw materials (peat, coir, plant fibres, barks) and has never been detected in products. It originates from industrial processes irrelevant to growing media. Testing creates unnecessary burden without safety benefit.

Amendment 566

Proposal for a regulation

Annex IV – paragraph 1 – point 2

Regulation (EU) 2019/1009

Annex II – Part II

Text proposed by the Commission	Amendment
(2) Iin Annex II, Part II, is amended as follows:	deleted
(a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is deleted;
(b) in CMC 3: COMPOST, point 1(d) is replaced by the following:
‘(d) composting additives which are necessary to improve the process performance or the environmental performance of the composting process, provided that the total concentration of all additives does not exceed 5% of the total input material weight; or’;

Or. en

Justification

Safety of the intended use of the EU fertilising product should be demonstrated in a manner comparable to that achieved through other regulatory regimes for products intended for use on arable soil or crops, like Regulation 1107/2009. All substances used in an EU fertilising products, regardless of the quantity in which they are manufactured or imported, should be registered, as a minimum, with the information requirements set out by Regulation (EC) No 1907/2006 for substances manufactured or imported in quantities of 10 to 100 tonnes per company per year, together with a chemical safety report covering their use in a fertilising product.

Amendment 567

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2

Regulation (EU) 2019/1009

Annex II – Part II

Text proposed by the Commission	Amendment
(2) [...]	deleted

Or. en

Amendment 568

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2

Regulation (EU) 2019/1009

Annex II – part II

Text proposed by the Commission	Amendment
[...]
[...]	[...] [...]	deleted

Or. en

Amendment 569

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point -a (new)

Regulation (EU) 2019/1009

Annex II – Part II

Text proposed by the Commission	Amendment
	(-a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 1, point (f) is deleted

Or. en

Amendment 570

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point a

Text proposed by the Commission	Amendment
(a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is deleted;	deleted

Or. en

Amendment 571

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point a

Text proposed by the Commission	Amendment
(a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is deleted;	deleted

Or. en

Amendment 572

Martin Hojsík, Sigrid Friis, Michal Wiezik, Pascal Canfin, Grégory Allione, Yvan Verougstraete

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point a

Text proposed by the Commission	Amendment
(a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is deleted;	(a) in CMC 1: VIRGIN MATERIAL SUBSTANCES AND MIXTURES, point 2 is replaced as follows:
	a) Substances classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the following hazard classes or categories:
	- Germ cell mutagenicity, category 1A or 1B;
	- Carcinogenicity, category 1A or 1B;
	- Reproductive toxicity, category 1A or 1B;
	- Specific target organ toxicity, repeated exposure, category 1;
	- Endocrine disruptor for human health, category 1;
	- Endocrine disruptor for the environment, category 1; and
	- Persistent, bioaccumulative and toxic or very persistent and very bioaccumulative properties
	whose actual quantities placed on the market are lower than 10 tonnes per year, incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing:
	(i) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and
	(ii) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation.
	b) Polymers are exempt from point a).;

Or. en

Justification

The amendment facilitates simplification for economic operators, as no longer requiring data from all substances used in EU fertilising products as required by the current Fertilizers Reg. (2019/1009), yet offering minimum level of safety when placing fertilizing products on the market.

Amendment 573

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point b

Regulation (EU) 2019/1009

Annex II – part II – CMC3

Text proposed by the Commission	Amendment
(b) in CMC 3: COMPOST, point 1(d) is replaced by the following:	deleted
‘(d) composting additives which are necessary to improve the process performance or the environmental performance of the composting process, provided that the total concentration of all additives does not exceed 5% of the total input material weight; or;’

Or. en

Amendment 574

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point c

Regulation (EU) 2019/1009

Annex II – part II – CMC4

Text proposed by the Commission	Amendment
(c) CMC 4: FRESH CROP DIGESTATE is amended as follows:	deleted
(i) point 1(b) is replaced by the following:
‘(b) digestion additives which are needed to improve the process performance or the environmental performance of the digestion process, provided that the total concentration of all additives does not exceed 5% of the total input material weight; or;’
‘3d. Additives needed in the post processing of a digestate or a fraction in accordance with points 3a, 3b and 3c may be used provided that the concentration of the additives needed in each of the processes does not exceed 5 % of the weight of the digestate or fraction used as input in the respective process.;’

Or. en

Amendment 575

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point d

Regulation (EU) 2019/1009

Annex II – part II – CMC5

Text proposed by the Commission	Amendment
(d) CMC 5: DIGESTATE OTHER THAN FRESH CROP DIGESTATE is amended as follows	deleted
(i) point 1(d) is replaced by the following:
‘(d) digestion additives which are necessary to improve the process performance or the environmental performance of the digestion process, provided that the total concentration of all additives does not exceed 5% of the total input material weight; or;’
‘3d. Additives needed in the post processing of a digestate or a fraction in accordance with points 3a, 3b and 3c may be used, provided that the concentration of the additives needed in each of the processes does not exceed 5% of the weight of the digestate or fraction used as input in the respective process.;’

Or. en

Amendment 576

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point e

Regulation (EU) 2019/1009

Annex II – part II – CMC6

Text proposed by the Commission	Amendment
(e) in CMC 6: FOOD INDUSTRY BY-PRODUCTS, point 2 is deleted;	deleted

Or. en

Amendment 577

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point e a (new)

Regulation (EU) 2019/1009

Annex II – Part II – CMC 7

Text proposed by the Commission	Amendment
	(e a) In Annex II, Part II, CMC 7, point 1 is replaced by the following:
	An EU fertilising product may contain micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which have been intentionally added for the purpose of performing any function specified in PFC 6(A) laid down in Annex I, provided that:(a) the micro-organism belongs to one of the following groups:(i) Azotobacter spp.;(ii) Mycorrhizal fungi;(iii) Rhizobium spp.;(iv) Azospirillum spp.; or(b) the micro-organism has been demonstrated by the manufacturer to comply with the general safety and agronomic efficiency criteria established by the Commission pursuant to Article 42(1), and this compliance has been confirmed by a notified body as part of the conformity assessment procedure.'
	(In Annex II, Part II)

Or. en

Justification

The current positive list under CMC 7 includes only four groups of micro-organisms, blocking market access for most microbial plant biostimulants. According to EBIC data, 88% of sector participants cannot access the EU market because their micro-organism is not listed. A criteria-based approach would allow safe micro-organisms meeting general safety criteria to be used without individual Commission assessment, while maintaining safety through notified body verification.

Amendment 578

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point f

Regulation (EU) 2019/1009

Annex II – part II – CMC8

Text proposed by the Commission	Amendment
(f) in CMC 8: NUTRIENT POLYMERS, point 1 is replaced by the following:	deleted
‘1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in point 1 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.;’

Or. en

Amendment 579

Salvatore De Meo, Flavio Tosi, Massimiliano Salini, Letizia Moratti

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point f

Regulation (EU) No 2019/1009

Annex II – Part II – CMC 8: NUTRIENT POLYMERS

Text proposed by the Commission	Amendment
1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in point 1 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.;	1. An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in point 1 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances. The polymer may additionally perform stabilising or structural functions;

Or. en

Amendment 580

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point f a (new)

Regulation (EU) 2019/1009

Annex II – Part II – CMC 9 – point 1 c

Text proposed by the Commission	Amendment
	(f a) In Annex II, Part II, CMC 9, point 1(c) is replaced by the following:
	'(c) a polymer that is used to bind together component materials of a growing medium and that either: (i) meets the biodegradability criteria set out in point 3; or (ii) is contained in a growing medium that bears the information set out in Annex III, Part I, point 7.'
	(CMC 9 binders biodegradability)

Or. en

Justification

Under CMC 9(1)(c), binders for growing media are exempt from biodegradability criteria and rely on labelling ("not to be used in contact with soil"). This is appropriate for mineral wool slabs (recycled, never reach soil) but problematic for plant plugs and propagation blocks that do enter soil.

Amendment 581

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point g

Regulation (EU) 2019/1009

Annex II – part II – CMC10

Text proposed by the Commission	Amendment
(g) in CMC 10: DERIVED PRODUCTS WITHIN THE MEANING OF REGULATION (EC) No 1069/2009, the table, point 1.3 is replaced by the following:	deleted
‘1.3. Additives needed in the processing referred to in points 1.1 and 1.2 may be used, provided that the concentration of the additives needed in each of the processes does not exceed 5% of the weight of the processed manure or fraction used as input in the respective process.;’

Or. en

Amendment 582

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point h

Regulation (EU) 2019/1009

Annex II – part II – CMC11

Text proposed by the Commission	Amendment
(h) in CMC 11: BY-PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2008/98/EC, point 2 is deleted;	deleted

Or. en

Amendment 583

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point h

Text proposed by the Commission	Amendment
(h) in CMC 11: BY-PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2008/98/EC, point 2 is deleted;	deleted

Or. en

Amendment 584

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point i

Regulation (EU) 2019/1009

Annex II – part II – CMC12

Text proposed by the Commission	Amendment
(i) in CMC 12: PRECIPITATED PHOSPHATE SALTS AND DERIVATES, point 13 is deleted;	deleted

Or. en

Amendment 585

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point i

Text proposed by the Commission	Amendment
(i) in CMC 12: PRECIPITATED PHOSPHATE SALTS AND DERIVATES, point 13 is deleted;	deleted

Or. en

Amendment 586

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point j

Text proposed by the Commission	Amendment
(j) in CMC 13: THERMAL OXIDATION MATERIALS OR DERIVATES, point 8 is deleted;	deleted

Or. en

Amendment 587

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point j

Regulation (EU) 2019/1009

Annex II – part II – CMC13

Text proposed by the Commission	Amendment
(j) in CMC 13: THERMAL OXIDATION MATERIALS OR DERIVATES, point 8 is deleted;	deleted

Or. en

Amendment 588

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point k

Regulation (EU) 2019/1009

Annex II – part II – CMC14

Text proposed by the Commission	Amendment
(k) in CMC 14: PYROLYSIS AND GASIFICATION MATERIALS, point 7 is deleted;	deleted

Or. en

Amendment 589

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point k

Text proposed by the Commission	Amendment
(k) in CMC 14: PYROLYSIS AND GASIFICATION MATERIALS, point 7 is deleted;	deleted

Or. en

Amendment 590

Katrin Langensiepen

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point l

Regulation (EU) 2019/1009

Annex II – part II – CMC15

Text proposed by the Commission	Amendment
(l) in CMC 15: RECOVERED HIGH PURITY MATERIALS, point 10 is deleted;	deleted

Or. en

Amendment 591

Per Clausen, Anja Hazekamp

Proposal for a regulation

Annex IV – paragraph 1 – point 2 – point l

Text proposed by the Commission	Amendment
(l) in CMC 15: RECOVERED HIGH PURITY MATERIALS, point 10 is deleted;	deleted

Or. en

Amendment 592

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 2 a (new)

Regulation (EU) 2019/1009

Annex II – Part II – CMC 15 a (new)

Text proposed by the Commission	Amendment
	(2a) CMC 15a — Component materials that comply with horizontal criteria established on the basis of the general delegation of powers under Article 42(1) An EU fertilising product may contain component materials for which compliance with the criteria and methodology established on the basis of Article 42(1) has been demonstrated in the conformity assessment. Such materials need not be individually listed in Annex II, provided that: (a) they comply with the safety, environmental and agronomic criteria established pursuant to Article 42(1); (b) they comply with any additional specifications laid down in the delegated act adopted pursuant to Article 42(1). The use of CMC 15a shall be without prejudice to the application of other component material categories set out in this Annex.

Or. nl

Amendment 593

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 2 b (new)

Regulation (EU) 2019/1009

Annex III

Text proposed by the Commission	Amendment
	(2 b) In Annex III, Part II, PFC 4, the following points are added:
	'5. By way of derogation from Part I, point 2(d), where the declared nutrient content is subject to natural variation, the manufacturer may indicate the nutrient content as a range, provided that:
	(a) the range does not exceed 25% of the midpoint value;
	(b) the label indicates that the actual content may vary within the stated range.
	Where a manufacturer produces growing media within a defined product group sharing the same component materials and production process but differing in proportions or minor additives, the manufacturer may use a single product designation for that group, provided that:
	(a) the label clearly indicates the product group designation;
	(b) the specific composition for each product variant is made available digitally in accordance with Article 11b.'

Or. en

Justification

Parameters such as nutrient contents, pH, and electrical conductivity vary naturally across batches. When classified as PFC 7 (blends), all labelling requirements for individual constituents apply (granulation for lime, full nutrient declarations for fertilisers).

Amendment 594

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 2 a (new)

Regulation (EU) 2019/1009

Annex III –Part III – point 3

Text proposed by the Commission	Amendment
	(2 a) In Annex III, Part III, point 3 is replaced by the following:
	3. For EU fertilising products belonging to PFC 4 (growing medium), the declared quantity by volume may have a relative deviation of up to minus 5 %. No upper deviation limit shall apply.
	(Tolerance rules for PFC 4 volume)

Or. en

(Annex III, Part III, point 3)

Justification

Amendment 595

Sander Smit

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point e – point i a (new)

Regulation (EU) 2019/1009

Annex IV – Part I

Text proposed by the Commission	Amendment
	(i a) In Annex IV, Part I, the following point 4a is inserted:'
	4a. By way of derogation from points 1 and 4, for EU fertilising products belonging to PFC 4 (growing medium) that contain only component materials belonging to CMC 1, CMC 2, CMC 8, CMC 9 or CMC 11, the manufacturer may apply the conformity assessment procedure set out in Module A (internal production control) as described in Part II of this Annex.'

Or. en

Justification

Most growing media require Module D1 conformity assessment, imposing disproportionate costs for low-risk products. Most national rules allow self-declaration, reflecting the low risk to health and environment.

Amendment 596

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point a – point i

Regulation (EU) 2019/1009

Annex IV – Part II – point 4.2 – first sentence

Text proposed by the Commission	Amendment
The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product or type in electronic form and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market.;	The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product or type in electronic form and keep it together with the technical documentation at the disposal of the authorities for 5 years after the EU fertilising product has been placed on the market.;

Or. en

Amendment 597

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point a – point ii

Regulation (EU) 2019/1009

Annex IV – Part II – Module A – point 4.3

Text proposed by the Commission	Amendment
4.3. The manufacturer shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority.;	4.3. The manufacturer shall, further to a reasoned request from competent authorities, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a swift manner and without undue delay and in a language which can be easily understood by authorities.;

Or. en

Amendment 598

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point b – point ii

Regulation (EU) 2019/1009

Annex IV – Part II – Module A1 – point 5.2 – first sentence

Text proposed by the Commission	Amendment
The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product type in electronic form and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market.;	The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product type in electronic form and keep it together with the technical documentation at the disposal of the authorities for 5 years after the EU fertilising product has been placed on the market.;

Or. en

Amendment 599

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point b – point iii

Regulation (EU) 2019/1009

Annex IV – part II – Module A1 – point 5.3

Text proposed by the Commission	Amendment
5.3. The manufacturer shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority.;	5.3. The manufacturer shall, further to a reasoned request from a competent authorities, provide it, in electronic form in a swift manner and without undue delay, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by authorities;

Or. en

Amendment 600

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point c – point i

Regulation (EU) 2019/1009

Annex IV – part II – point (c) – point 3.2 (a)

Text proposed by the Commission	Amendment
(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his or her name, postal address and digital contact as well,;	(a) the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, their name, postal address and digital contact as well,;

Or. en

Amendment 601

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point d – point i

Regulation (EU) 2019/1009

Annex IV – part II – Module C – point 3.2 – first sentence

Text proposed by the Commission	Amendment
The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product type in electronic form and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market.;	The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product type in electronic form and keep it together with the technical documentation at the disposal of the national or European authorities or bodies for 5 years after the EU fertilising product has been placed on the market.;

Or. en

Amendment 602

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point d – point ii

Regulation (EU) 2019/1009

Annex IV – part II – Module C – point 3.3

Text proposed by the Commission	Amendment
3.3. The manufacturer shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority.;	3.3. The manufacturer shall, further to a reasoned request from a national or European authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by authorities;

Or. en

Amendment 603

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point e – point i

Regulation (EU) 2019/1009

Annex IV – part II – Module D1 – point 5.2 – first indent

Text proposed by the Commission	Amendment
the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, his or her name, postal address and digital contact as well,;	the name, postal address and digital contact of the manufacturer and, if the application is lodged by the authorised representative, their name, postal address and digital contact as well,;

Or. en

Amendment 604

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point e – point ii

Regulation (EU) 2019/1009

Annex IV – part II – Module D1 – point 7.2 – first sentence

Text proposed by the Commission	Amendment
The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product or type in electronic form and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market.;	The manufacturer shall draw up an EU declaration of conformity for an EU fertilising product or type in electronic form and keep it together with the technical documentation at the disposal of the national and European authorities or bodies for 5 years after the EU fertilising product has been placed on the market.;

Or. en

Amendment 605

Proposal for a regulation

Annex IV – paragraph 1 – point 3 – point e – point iii

Regulation (EU) 2019/1009

Annex IV – part II – Module D1 – point 7.3

Text proposed by the Commission	Amendment
The manufacturer shall, further to a reasoned request from a competent national authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority.	The manufacturer shall, further to a reasoned request from a national or European authority, provide it, in electronic form, with all the information and documentation necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by authorities.

Or. en