1. ------ IND- 2020 0832 F-- EN- ------ 20201230 --- --- PROJET

FRENCH REPUBLIC Ministry of the Ecological Transition Ministry of Health and Solidarity Ministry of Justice

Decree No of

on the provision of information identifying endocrine disruptors in a product

NOR: TREP
Decree No 2021-1110 of 23 August 2021 on the provision of information identifying endocrine disruptors in a product

Groups concerned: Anyone who places on the market products intended for consumers which, at the end of the manufacturing process, contain substances which the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has indicated as having proven, presumed or suspected endocrine-disrupting properties
Purpose: Article 1 of this Decree creates the necessary national provisions on providing information identifying endocrine disruptors in a product.
Entry into force: The Decree shall enter into force on 1 January 2022.
Notice: Article 13-II of Law No 2020-105 of 10 February 2020 against waste and for the circular economy, known as ‘AGEC’, provides for the use of a Council of State decree to set the terms of application for providing information identifying endocrine disruptors in a product placed on the market. The objective indicated in the explanatory statement for this Article is ‘to provide citizens with transparent information on the presence of a substance with endocrine-disrupting properties in products. Thus, it provides that anyone placing on the market products containing substances with endocrine-disrupting properties according to ANSES shall publish a list of these products and the substances that each of them contains. Publication shall be carried out in an open format allowing collaborative platforms to use this information and thus better inform consumers.’
The Second National Strategy on Endocrine Disruptors (SNPE2) includes a focus on improving consumer information. ANSES is already strongly involved through the establishment of lists of substances exhibiting endocrine-disrupting properties (action No 3 of the SNPE2). This provision is part of this dynamic and aims to provide citizens with transparent information on the presence of substances with endocrine-disrupting properties in products, in terms of substances, mixtures, articles and food. Thus, for the purposes of the Article, the following are considered products under Article L. 5232-5 of the Public Health Code: substances, mixtures and articles as defined in Article 3 of Regulation (EU) No 1907/2006 (with the exception of medicines), biocidal products as defined in Article 3 of Regulation (EU) No 528/2012, plant protection products as defined in Article 2 of Regulation (EC) No 1107/2009, medical devices as defined in Article 2 of Regulation (EU) No 2017/745, materials and articles, including active and intelligent materials, intended to come into contact with food as defined in Article 2 of Regulation (EU) No 1935/2004, toys as defined in Article 2 of Directive 2009/48/EC, cosmetic products as defined in Article 2 of Regulation (EC) No 1223/2009 and products as defined in Article 2 of Directive 2001/95/EC and food as defined in Article 2 of Regulation (EC) No 178/2002.
The obligation to make available information identifying endocrine disruptors in a product placed on the market shall apply no later than six months after the publication of the Order listing substances with qualified endocrine disrupting

Purpose: Article 1 of this Decree creates the necessary national provisions on providing information identifying endocrine disruptors in a product.

Entry into force: The Decree shall enter into force on 1 January 2022.

Notice: Article 13-II of Law No 2020-105 of 10 February 2020 against waste and for the circular economy, known as ‘AGEC’, provides for the use of a Council of State decree to set the terms of application for providing information identifying endocrine disruptors in a product placed on the market. The objective indicated in the explanatory statement for this Article is ‘to provide citizens with transparent information on the presence of a substance with endocrine-disrupting properties in products. Thus, it provides that anyone placing on the market products containing substances with endocrine-disrupting properties according to ANSES shall publish a list of these products and the substances that each of them contains. Publication shall be carried out in an open format allowing collaborative platforms to use this information and thus better inform consumers. Information that may be provided could include, for example: the product category, the trade name of the product, the product reference, the chemical name of the substance with endocrine-disrupting properties, the chemical formula, the CAS number and the EC number of the substance exhibiting endocrine-disrupting properties, or the usual and trade names of the substance exhibiting endocrine-disrupting properties.’ The Second National Strategy on Endocrine Disruptors (SNPE2) includes a focus on improving consumer information. ANSES is already strongly involved through the establishment of lists of substances exhibiting endocrine-disrupting properties (action No 3 of the SNPE2). This provision is part of this dynamic and aims to provide citizens with transparent

information on the presence of substances with endocrine-disrupting properties in products, in terms of substances, mixtures, articles and food. Thus, for the purposes of the Article, the following are considered products under Article L5232-5 of the Public Health Code: substances, mixtures and articles as defined in Article 3 of Regulation (EU) No 1907/2006 (with the exception of medicines), biocidal products as defined in Article 3 of Regulation (EU) No 528/2012, plant protection products as defined in Article 2 of Regulation (EC) No 1107/2009, medical devices as defined in Article 2 of Regulation (EU) No 2017/745, materials and articles, including active and intelligent materials, intended to come into contact with food as defined in Article 2 of Regulation (EU) No 1935/2004, toys as defined in Article 2 of Directive 2009/48/EC, cosmetic products as defined in Article 2 of Regulation (EC) No 1223/2009 and products as defined in Article 2 of Directive 2001/95/EC and food as defined in Article 2 of Regulation (EC) No 178/2002.

References: The text can be consulted on the Légifrance website (https://www.legifrance.fr).
properties, according to the level of scientific evidence of verified, presumed or suspected persons and the list of product categories presenting a particular risk of exposure. The obligation to provide information on the presence of endocrine disrupting substances classified as suspected shall apply only to the product categories with a particular risk of exposure laid down in that Order.
References: the public health code amended by the decree can be consulted, in its version resulting from this amendment, on the Légifrance website (https://www.legifrance.gouv.fr).

The Prime Minister,

On the basis of the report by the Minister for the Ecological Transition,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;

Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC;

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;

Having regard to Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, and in particular Notification No ……………….;

Having regard to the Environmental Code, in particular Article L541-1-1 thereof;

Having regard to the Penal Code, in particular Article R610-1 thereof;

Having regard to the Public Health Code, in particular Article L5232-5 thereof, as amended by Article 13 of Law No 2020-105 of 10 February 2020 against waste and for the circular economy;

Having heard the Council of State (public works division),

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;
Having regard to Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, and in particular Notification No 2020/832/F;
Having regard to the Environmental Code, in particular Article L. 541-9-1 thereof;
Having regard to the Penal Code, in particular Article R. 610-1 thereof;
Having regard to the Public Health Code, in particular Article L. 5232-5;
Having regard to Law No 2020-105 of 10 February 2020 against waste and for the circular economy, in particular Articles 13 and 130;
Having regard to notification No 2020/0832/F sent to the European Commission on 21 December 2020 and its replies of 25 January and 22 March 2021;
Having heard the Council of State (social division),
Hereby decrees as follows:

Article 1

After Section 2 of Chapter II of Title III of Book II of Part 5 of the Public Health Code (regulatory section), a Section 3 is inserted which reads as follows:
After Section 2 of Chapter II of Title III of Book II of Part 5 of the Public Health Code, a Section 3 is inserted which reads as follows:

‘Section 3: Information on endocrine disruptors in products
‘Section 3
‘Information on endocrine disruptors in products

‘Subsection 1: Definition of the list of substances exhibiting proven, presumed or suspected endocrine-disrupting properties
‘Subsection 1
‘Definition of the list of substances exhibiting proven, presumed or suspected endocrine-disrupting properties and of the categories of products presenting a particular risk of exposure

‘Article R5232-19 - For the purposes of this Section, substances, mixtures and articles as defined in Article 3 of Regulation (EU) No 1907/2006 (with the exception of medicines), and food as defined in Article 2 of Regulation (EC) No 178/2002 are considered products within the meaning of Article L5232-5.
‘Article R. 5232-19.-For the purposes of this section, foodstuffs as defined in Article 2 of Regulation (EC) No 178/2002 and substances, mixtures and articles as defined in Article 3 of Regulation (EU) No 1907/2006, with the exception of medicinal products, shall be considered to be products within the meaning of Article L. 5232-5.
‘A joint order of the Ministers for Health and for the Environment shall, after consulting the French Agency for Food, Environmental and Occupational Health & Safety, lay down:
‘1. The list of substances exhibiting endocrine-disrupting properties mentioned in I of Article L. 5232-5, divided into two categories, proven and presumed, according to the level of scientific proof;
‘2. The list of substances with suspected endocrine disrupting properties, mentioned in II of Article L. 5232-5;
‘3. The categories of products presenting a particular exposure risk as mentioned in II of Article L. 5232-5 with regard to the populations exposed, the conditions of use and disposal of these products and other relevant criteria.

‘I. - A joint order of the Ministers for Health and for the Environment shall, after consulting the French Agency for Food, Environmental and Occupational Health & Safety, lay down the list of substances exhibiting endocrine-disrupting properties mentioned in I of Article L5232-5, divided into two categories, proven and presumed, according to the level of scientific proof.
‘Subsection 2
‘Public availability of information

‘II. - A joint order of the Ministers for Health and for the Environment shall, after consulting the French Agency for Food, Environmental and Occupational Health & Safety, lay down the list of substances exhibiting suspected endocrine-disrupting properties mentioned in II of Article L5232-5.
‘Article R. 5232-20 - I. -The information provided for in I and II of Article L. 5232-5 shall be made available in a paperless format, accessible free of charge and reusable in such a way as to allow aggregation. To that end, any person who places products on the market within the meaning of Article L. 5232-5 shall make available the information either on a dedicated web page containing an application programming interface or by means of an application designated

‘III. - A joint order of the Ministers for Health and for the Environment shall, after consulting the French Agency for Food, Environmental and Occupational Health & Safety, lay down the categories of products presenting a particular exposure risk as mentioned in II of Article L5232-5 with regard to the populations exposed, the conditions of use and disposal of these products and other relevant criteria.
by joint order of the ministers responsible for health and the environment.
‘If the product concerned is also the subject of an obligation to inform consumers under Article L. 541-9-1 of the Environmental Code, the information provided for in I and II of Article L. 5332-5 of this Code shall be made available on the same media as that provided for the provision of information on the environmental qualities and characteristics of those products or categories of products defined pursuant to Article L. 541-9-1 of the Environmental Code.
‘A joint order of the Ministers for Health and for the Environment shall set out the procedures relating to the contents and conditions for presenting the information provided for in I and II of Article L. 5232-5 of this code.
‘The information provided for in I and II of Article L. 5232-5 shall be made available to the public for each product no later than six months after publication of the decree mentioned in Article R. 5232-19 placing it on the list.

‘Subsection 2: Public availability of information
‘Subsection 3
‘Criminal penalties

‘Article R5232-20 - I. - The information provided for in I and II of Article L5232-5 shall be available on a public database with a programming interface accessible via the Internet. A joint order of the Ministers for Health and for the Environment shall set out the contents and conditions for presenting this information.
‘Article R. 5232-21. -Failure to make information provided for in I and II of Article L. 5232-5 available to the public under the terms defined in Article R. 5232-20 is punishable by the fine laid down for five category offences.
‘Failure to comply with the time limit provided for in Article R. 5232-20 shall be punishable by the fine provided for category five offences.

‘II. – The information provided for in I and II of Article L5232-5 shall be made available to the public no later than 18 months after publication of the decrees mentioned in Article R5232-19.’

‘Subsection 3: Criminal penalties

‘Article R5232-21 - Failure to make information identifying the presence of endocrine disruptors in products defined under the terms of Article R5232-20 available to the public under the terms of Article L5232-5 shall be punishable by the fine for category five offences.

Failure to comply with the time limit provided for in II of Article R5232-20 shall be punishable by the fine provided for category five offences.

‘Article R5232-22 - Repetition of the offences laid down in Article R5232-21 shall be sanctioned pursuant to Articles 132-11 and 132-15 of the Penal Code.’
‘Article R. 5232-22 - Repetition of the offences laid down in Article R. 5232-21 shall be sanctioned pursuant to Articles 132-11 and 132-15 of the Penal Code.’

Article 2

The Minister for the Ecological Transition, the Minister for Solidarity and Health and the Keeper of the Seals, Minister for Justice, shall be responsible, within the scope of their respective competences, for the implementation of this Decree, which shall be published in the Official Journal of the French Republic.
This Decree shall enter into force on 1 January 2022.

Done on
Article 3

The Minister for the Ecological Transition, the Keeper of the Seals, Minister for Justice and Minister for Solidarity and Health shall be responsible, within the scope of their respective competences, for the implementation of this Decree, which shall be published in the Official Journal of the French Republic.

Done on 23 August 2021.

Jean Castex
By the Prime Minister:

The Minister for the Ecological Transition,

Barbara POMPILI

The Minister for Solidarity and Health
The Keeper of the Seals, Minister for Justice,
Éric Dupond-Moretti

Olivier VERAN

The Keeper of the Seals, Minister for Justice

Eric DUPONT-MORETTI
The Minister for Solidarity and Health,
Olivier Véran