What changed between the plenary report and the adopted text

Article 3 – paragraph 1 – point 2 – point c, Article 6 – paragraph 6 – subparagraph 1: 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 a swift manner.’

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 4 – point a, Article 8 – paragraph 2 – subparagraph 1: 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 directly 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).’

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 4 – point c, Article 8 – paragraph 8 – subparagraph 1: 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 to those authorities, upon request.

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 4 – point c, Article 8 – paragraph 8 – subparagraph 2: On request, importers shall make the EU declaration of conformity available to other economic operators in electronic form in a swift manner.

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 5 – point a, Article 9 – paragraph 2 – subparagraph 1: 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 directly 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.

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 7, Article 16 – paragraph 5 – subparagraph 1: The EU declaration of conformity shall be provided in a machine-readable format through which it can be directly accessed.

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b, Article 42 – paragraph 4a – introductory part: 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 and the notifying bodies 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 criteria and methodology shall 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:

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b, Article 42 – paragraph 4 aa (new): The following paragraph 4aa is inserted: / ‘4aa. The Commission may also adopt delegated acts pursuant to paragraph 1 amending Annex II to establish general criteria and a methodology for the assessment of materials and processing methods other than those already listed in Annex II, excluding micro-organisms, which may be used as component materials in EU fertilising products where compliance with those criteria is demonstrated in the conformity assessment. The criteria and methodology shall, as a minimum, provide for the consideration of scientific or technical information supporting safe sourcing, processing and use of the material.’

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b, Article 42 – paragraph 4 ab (new): The following paragraph 4 ab is inserted: / 4 ab. By [12 months after the date of entry into force of this amending Regulation] the Commission shall adopt a delegated act to establish the criteria and methodology and upon assessment to create a corresponding new category for materials and processing methods other than those already listed in Annex II, excluding micro-organisms, which may be used as component materials in EU fertilising products provided that compliance with those criteria is demonstrated in the conformity assessment. The criteria and methodology shall aim to ensure safe sourcing, processing and use of the material. This new category shall be established without prejudice to the application of other component material categories set out in Annex II.’

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b a (new), Article 42 – paragraph 5 a (new): (b a) The following paragraph 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 sufficient to ensure a high level of protection for human health and the environment, 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 water; 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 them and, where necessary, amend them to ensure such consistency. For that purpose, the Commission shall, where relevant, request scientific opinions from the European Food Safety Authority to assess risks specific to f…

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b b (new), Article 42 – paragraph 8 a (new): (b b) The following paragraph is added: ‘8a. The Commission shall adopt the first delegated act pursuant to paragraph 4a by ... [18 months after the entry into force of this Regulation].’

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b c (new), Article 49 a (new): (b c) ‘Article 49a / Review / The Commission shall periodically assess 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, taking into account national practices, and the objectives of Regulation (EU) 2019/1009. This review shall be carried out for the first time no later than two years after the date of application of this amending Regulation.’

Regulation (EU) No 2019/1009

Article 3 – paragraph 1 – point 9 – point b d (new), Article 49 aa (new): (b d) By [insert date: 12 months after entry into force], the Commission shall submit a report to the European Parliament and the Council assessing the requirements for fertilising product blends where the primary component is one or more growing media belonging to PFC 4. / The report shall, in particular, evaluate the conditions for adjusting nutrient content, pH value or biological activity, updated labelling requirements, and appropriate conformity assessment procedures for such blends and it may accompany, where appropriate, amendments to this Regulation.

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 2, Annex I – section 1.2.1.5: (2) in Annex I, section 1.2.1.5 is replaced by the following: The text on the label shall be legible. For the purpose of this section, a label shall be considered legible if 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) appropriate letter spacing for the selected typeface to be easily legible; (d) appropriate line spacing 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 and the intended user. 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. However, where the contents of the package do not exceed 125 ml, the label elements referred to in Article 17(1) may use a font size where the x-height is equal to or greater than 0.9 mm. These characteristics shall be further clar…

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 3, Annex I – section 1.5.1.2: 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, the name, the digital contact and the telephone number of the suppliers of the substance or mixture unless this telephone number is directly available through the digital contact;

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 5, Annex I – section 1.5.2.4.1 – point (b): (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:

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 7, Annex I – section 1.5.2.4.3 – point (b): (b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II;

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 7 a (new), Annex I – section 1.5.2.4.3a (new): (7 a) in Annex I, section 1.5.2.4.3a is added: '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’;’

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 7 b (new), Annex I – section 1.5.2.5.a (new): (7 b) in Annex I, section 1.5.2.5a is added: Labelling of ink cartridges where the contents do not exceed 150 ml. / 1.5.2.5a1: 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 ink cartridge do not exceed 150 ml / (b) the outer packaging complies with the provisions laid out in Article 17.; and / (c) keep the hazard information on the outer packaging is kept with the printer / 1.5.2.5a.2: Where 1.5.2.5a.1 applies the label on the ink cartridge and any intermediate packaging shall contain at least: / (a) the product identifier in accordance with Article 18(2) for substances and Article 18(3) for mixtures; / (b) where applicable the pictograms; / (c) where applicable the unique formula identifier; / (d) name, registered name or trademark of the supplier; and / (e) telephone number or digital contact / 1.5.2.5a.3: Where 1.5.2.5a.1 applies and the contents of the ink cartridge do not exceed 30 ml the information required by 1.5.2.5a.1 may be further reduced so that the label on the ink cartridge shall contain at least: / (a) the product identifier in accordance with Article 18(2) for substances and Article 18(3)) for mixtures; and / (b) where applicable the following pictograms: GHS01, GHS05, GHS06, GHS08. GHS07, GHS09, Where more than two pictograms are assigned GHS06 and GHS08 may take precedence over GHS01 and GHS05.

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 8, Annex I – section 1.6 – point (b a) new: (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’;

Regulation (EC) No 1272/2008

Annex I – paragraph 1 – point 9, Annex I – part 5 – point b: (b) For a substance or a mixture supplied at a fuel service station the copy of the following label elements referred to in Article 17.1, points (c) to (h) shall be provided on a visible place on or next to the respective pump: The unique formula identifier referred to in Article 25(7) does not need to be provided.

Regulation (EU) No 2019/1009

Annex IV – paragraph 1 – point 2 – point a, ANNEX II – Part II – VIRGIN MATERIAL SUBSTANCES AND MIXTURES: (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, intentionally incorporated into the EU fertilising product, on their own or in a mixture, in a concentration equal or lower than the generic cut-off values set out in Article 11(3) of Regulation (EC) No 1272/2008, 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, insofar as relevant and available, Annex VIII to Regulation (EC) No 1907/2006, on the basis of available data, alternative methods pursuant to Article 13 and adaptations pursuant to Annex XI, and conducting new tests on vertebrate animals only as a last resort and where relevant, and / (ii) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 strictly limited to the exposure scenarios related…

Regulation (EU) No 2019/1009