Legal provisions of COM(2023)98 - Amendment of Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products

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dossier COM(2023)98 - Amendment of Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products.
document COM(2023)98 EN
date February 27, 2023

Contents

Article 1

Regulation (EU) 2019/1009 is amended as follows:

(1) Article 2 is amended as follows: 

(a)the following point (10a) is inserted:

‘(10a) “packaging” means a sealable receptacle holding not more than 1000 kg;’;

(b)the following point (16a)  is inserted:

‘(16a) “data carrier” means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;’;

(2) Article 6 is amended as follows:

(a)in paragraph 5, the following subparagraph is added:

‘The information referred to in the first subparagraph shall be provided either physically on the packaging or the accompanying document, digitally, or both. Where the information is provided digitally, the requirements set out for digital labels in Article 11b and the obligations set out in Article 11c shall apply.’;

(b)in paragraph 6, the following subparagraph is added:

‘The information referred to in the first subparagraph shall be provided physically on the packaging or the accompanying document or both physically on the packaging or the accompanying document and digitally. Where the information is provided digitally, the requirements set out for digital labels in Article 11b and the obligations set out in Article 11c shall apply.’;

(c)paragraph 7 is replaced by the following:

‘7. Manufacturers shall ensure that EU fertilising products are accompanied by the labelling elements required under Annex III, provided in the relevant form set out in Article 11a. Those labelling elements shall be:

(a)in a language which can be easily understood by end-users, as determined by the Member State concerned; 

(b)clear, understandable and intelligible;

(c)accessible for inspection purposes when the EU fertilising product is made available on the market.’;

(3) in Article 8, paragraph 4 is replaced by the following:

 ‘4.    Importers shall ensure that EU fertilising products are accompanied by the labelling elements required under Annex III, provided in the relevant form set out in Article 11a. Those labelling elements shall be:

(a)in a language which can be easily understood by end-users, as determined by the Member State concerned;

(b)accessible for inspection purposes when the EU fertilising product is made available on the market.’;

(4) the following Articles 11a, 11b and 11c are inserted:

‘Article 11a

Forms of labelling

1. Where EU fertilising products are made available on the market in a packaging to economic operators, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)on a label in a digital form (“digital label”); or.

(b)on a label in a physical form attached to that packaging or, for the labelling elements that cannot be provided on the label due to the packaging being too small, in a separate leaflet accompanying that packaging (“physical label”).

2. Where EU fertilising products are made available on the market without packaging to economic operators, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)on a digital label; or

(b)on a leaflet accompanying the EU fertilising product.

3. Where EU fertilising products are made available on the market in a packaging to end-users, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)on a physical label; or

(b)on a digital label and duplicated on a physical label.

By way of derogation from point b, the labelling elements marked with an asterisk in Annex III do not have to be duplicated on the physical label.

4. Where EU fertilising products are made available on the market without packaging to end-users, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)on a digital label; or

(b)in a leaflet accompanying the EU fertilising product. 

5. Where economic operators provide a digital label in accordance with this Article, they shall comply with the requirements set out in Articles 11b and 11c.

Article 11 - b Requirements for digital labels

1. The digital label shall include: 

(a)the information required pursuant to Article 6(6); 

(b)the CE marking and, where applicable, the identification number of the notified body, in accordance with Articles 17 and 18;

(c) all the labelling elements required under Annex III, with the exception of the production date where that date has been provided on the physical label.

2. The information referred to in paragraph 1 shall be provided in one place and separated from any information not provided under this Regulation. 

3. The digital label shall be:

(a)accessible free of charge;

(b)easily and directly accessible, without a need to register in advance, to download or install applications or to provide a password;accessible to all potential users in the Union;

(c)searchable; 

(d)presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access by those groups;

(e)available for a period of 5 years from the moment the EU fertilising product is placed on the market, including in case of an insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created it.

Where the digital label is available in more than one language, the choice of languages shall not be dependent on the geographical location.

4. A data carrier used for a digital label shall be printed or placed physically on the packaging or, where the EU fertilising products are made available on the market without a packaging, on the accompanying document or leaflet, visibly, legibly and in a way that allows it to be processed automatically by digital devices. 

Article 11 - c Obligations of economic operators providing a digital label

1. Economic operators providing a digital label shall not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the relevant information digitally.

2. Upon request by the end-users, or without such request where the digital label is temporarily unavailable at the time of purchase, economic operators making available on the market EU fertilising products to such end-users shall provide the information included on the digital label, by alternative means and free of charge.’;

(5) in Article 42, the following paragraphs 9 and 10 are added:

‘9. By [OP: please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation], the Commission shall adopt delegated acts in accordance with Article 44 to supplement Articles 11b and 11c by laying down specific requirements for the digital labelling of EU fertilising products and conditions for fulfilling the obligations of economic operators providing a digital label. Those requirements shall establish, in particular, the types of electronic technical solutions which economic operators may use for providing the digital label, and the alternative means for providing the information referred to in Article 11c(2). When adopting the delegated acts, the Commission shall: 

(a)ensure coherence with other relevant Union acts; 

(b)encourage innovation;  

(c)ensure technological neutrality by not limiting the choice of technology or equipment, within the bounds of compatibility and interference avoidance;

(d)ensure that the digital labelling does not compromise the safety of the end-user and the environment;

(e)take into account the level of digital readiness among end-users of EU fertilising products.  

10. The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Annex III, as regards the labelling information which economic operators may provide on a digital label only in accordance with Article 11a(3) point (b), in order to adapt that Annex to technical and scientific progress or to the level of digital readiness among end-users of EU fertilising products. When adopting the delegated acts, the Commission shall take into account the need to ensure a high level of protection of human health and the environment.’;

(6) Annex III is amended in accordance with Annex I to this Regulation;

(7) Annex IV is amended in accordance with Annex II to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from [OP: please insert the date = the first day of the month following 30 months after the date of entry onto force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.