Decree on the provision of information to identify endocrine disruptors in a product
Communication from the Commission - TRIS/(2020) 04671
Directive (EU) 2015/1535
Translation of the message 001
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
1. Structured Information Line
MSG 002 IND 2020 0832 F EN 21-12-2020 F NOTIF
2. Member State
3. Department Responsible
Direction générale des entreprises
Bât. Sieyès -Teledoc 151
61, Bd Vincent Auriol
75703 PARIS Cedex 13
3. Originating Department
Ministère de la transition écologique
Direction générale de la prévention des risques
Bureau des produits chimiques
1 place Carpeaux
92055 La Défense Cedex
4. Notification Number
2020/0832/F - C70A
Decree on the provision of information to identify endocrine disruptors in a product
6. Products Concerned
7. Notification Under Another Act
8. Main Content
Article 13 of the Law against waste and for a circular economy (known as the AGEC Law) introduced consumer information provisions on the presence of hazardous substances, some of which specifically concern endocrine disruptors.
The draft Decree of the Council of State, adopted pursuant to Article 13-II, creates the national provisions necessary to make available information identifying endocrine disruptors in a product on a public database with a programming interface that is accessible via the Internet.
The first ministerial orders provided for in the draft Decree, which will also be notified to the European Commission, will determine:
- lists of substances proven and presumed to be endocrine disrupting substances,
- the list of substances suspected of being endocrine disrupting substances,
- categories of products presenting particular exposure risks with regard to exposed populations, the conditions of use and disposal of these products and other relevant criteria, and
- details on the content of and conditions for presenting the information.
9. Brief Statement of Grounds
This provision comes under the second national strategy on endocrine disruptors (SNPE2, published in September 2019) 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. Endocrine disruptors are present in many everyday objects and have impacts on the environment and health (involved in many diseases).
10. Reference Documents - Basic Texts
Reference(s) to basic text(s): - Law No 2020-105 of 10 February 2020 (AGEC Law) against waste and for a circular economy
11. Invocation of the Emergency Procedure
12. Grounds for the Emergency
14. Fiscal measures
15. Impact assessment
16. TBT and SPS aspects
No - the draft has no significant impact on international trade.
No - the draft is neither a sanitary nor phytosanitary measure.
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
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Orgalim, representing Europe’s technology industries, does not support the provisions of these French draft decrees. Orgalim fears that the decrees will be a considerable burden for industry and create more confusion and fragmentation within the EU internal market, with very limited positive effects on the health of EU citizens and the environment.
Regulation of substances should take place at European level, for EU Member States to compete on a level playing field and reap the full benefits of the Internal Market, while delivering on health and environmental factors. It is essential to the efficiency and success of the Green Deal and the new EU Circular Economy Action Plan that requirements are developed on a harmonised basis, across all EU Member States. Orgalim calls on all Member States to refer to existing European procedures and Article 57 of REACH Regulation for the definition of hazardous substances. Moreover, regarding the Substances of Very High Concern in Products (SCIP) database, Orgalim has serious concerns about the workability, proportionality and value of these national provisions. We therefore call on France to first conduct a study on the overlap with future EU legislation as well as the usefulness, feasibility, proportionality and impact of these new requirements.
Dear Madam, Sir,
Please find attached the TNPC comments on the draft French Decree on the provision of information to identify endocrine disruptors in a product, notified in the EU TRIS database under n°2020/832/F.
Yours sincerely, TNPC secretariat
Please find Cefic's input for the TRIS Notification 2020/832/F and 2020/833/F.
IGNES supports the FIEEC position paper on this topic.
Fecc acknowledges the proposed French decree on ‘TRIS Notification 2020/832/F’ which proposes provisions to identify endocrine disruptors (EDs). In this context we would like to raise the following points on behalf of the European chemical distribution sector, above all on behalf of the many SMEs we represent:
1. The implications of this decree to the single market must be considered. Chemical distributors are fully engaged and support the initiative for a safer and a more sustainable approach in handling and distributing chemicals. We therefore acknowledge the objectives of the French initiative, as actors in the supply chain and as consumers. However, this decree will result to industries having to fulfil regulations that are implemented differently at each Member State. The introduction of such a national mandatory requirement: (1) is not aligned with European requirements, (2) jeopardises the free movement of goods between Member States, and (3) is not in line with the recently published Commission note on 'A renewed trade policy for a stronger Europe’ , which highlights that an even level playing field is paramount for improving the EU’s resilience and for building a model of open strategic autonomy.
2. European alignment in ED definitions must be based on science-based provisions. The EU's ‘Chemicals Strategy for Sustainability’ already includes a transversal definition of EDs and the scientific requirements that may apply for each substance under assessment. This decree must be compatible with European regulatory and scientific standards, which is under the jurisdiction of both EFSA and ECHA as reference authorities for its safety evaluation. Additionally, there may be chemical compounds and mixtures that may show endocrine activity but does not cause adverse effects post-evaluation. Data gathered from in-vivo testing and a sufficiently established Adverse Outcome Pathway (AOP)  should suffice the procedural identification of these EDs.
3. The EU Green Deal must result to regulatory harmonisation, not its fragmentation. As mentioned on the Fecc feedback on the Commission note on 'Chemical Strategy for Sustainability , a clear repartition of responsibilities between the EU agencies in other areas, the scientific committees, the Commission services and the authorities in the Member States would be needed in order to improve the assessment process. This is already the case under the Chemical Strategy for Sustainability's objective of a 'one-substance, one-assessment' approach. This decree proposed by France contradicts this principle as it identifies hazardous substances and EDs at a national level.
Fecc acknowledges that this decree signals a regulatory paradigm shift for the European chemical industry and companies that produce and distribute EDs. We look forward to further working with the Commission to establish a coherent regulatory framework and ensure that the objective on sustainability and harmonisation of the EU Green Deal are achieved.
FoodDrinkEurope position on the TRIS Notification 2020/832/F (France) - Decree on the provision of information to identify endocrine disruptors (ED)
FoodDrinkEurope is the organization representing Europe’s food and drink industry, composed of 294,000 businesses and 4.7 million workers and Europe’s largest manufacturing industry. We would like to comment on the French Decree, notified under, TRIS 2020/832/F, - on the provision of information to identify endocrine disruptors (EDs) in a product, which we believe diverts from the mandate already established by the EU’s ‘Chemicals Strategy for Sustainability’ published on 14 October 2020, and does not align with the positions and procedures from EU agencies such as EFSA or ECHA.
The objective of the Decree, which refers to Article 13-II of French Law No 2020-105 of 10 February 2020 against waste and for the circular economy, known as 'AGEC', is to provide consumers with transparent information on the presence of a substance with endocrine-disrupting properties in products placed on the French market. In particular, it declares in Article 1, Section 3, Subsection 1 that this information should be based on lists of substances with proven, presumed, or suspected endocrine-disrupting properties, which should be defined and laid down by the French government (Ministries for Health and for the Environment) after consultation of the French risk assessment body ANSES (French Agency for Food, Environmental and Occupational Health & Safety) and which should be publicly available.
FoodDrinkEurope would like to highlight the following concerns related to this Decree:
· Disruption of Single Market: the French Decree threatens the competitiveness of the industries that have to fulfil regulations that are implemented differently at each member state, the provision of information on products having to comply to a specific national regulation (and costs associated with) and the transport of goods with different specifications. This will disrupt the EU founding principle of the Single Market and common rules, thus reducing the competitiveness of the European food industry.
· European harmonization on definitions: The definition of EDs and the scientific criteria applicable are currently part of the EU ‘Chemicals Strategy for Sustainability’ and will be further harmonised in 2021 across the different regulations. Thus, we strongly believe that the French decree should fully align to European regulatory and scientific principles.
· Communication to consumers: Public information to consumers about the presence of EDs in products does not align with the principles set by the EU ‘Chemicals Strategy for Sustainability’ upon which only sufficient and appropriate information should be provided to the authorities to allow the identification of the EDs to enable their management. The average consumer lacks the needed expertise to understand the difference between endocrine activity and endocrine disruption, the complex concepts of having different lists for EDs classification, and the relevance of the simple presence of an EDs in a food product. The approach foreseen by the French Decree will lead consumers to interpret that the safety of final products included in the database is not ensured, and thus make decisions only on the basis of the lists of substances present. Regulated substances are authorised for use only when they are deemed safe, based on the scientific evidence available. We consider that regulating the use of EDs and managing the risk are the responsibility of the authorities and this responsibility should not be indirectly delegated to consumers.
So far, there is only a requirement on European level (REACH legislation) to provide information about chemicals intentionally added and listed as SVHC (Substances of Very High Concern) to the public. The threshold to provide this information is that the product contains a substance listed as SVHC at levels of 0.1 % or higher. This would also apply when a substance listed as SVHC is an ED.
· Science-based provisions: The classification as EDs must be based on sound science and validated at European level. We believe that ECHA and EFSA should be the reference authority for EDs – as they already did for plant protection products and biocides. This is highly important especially if the presence of EDs is communicated to consumers. The risk to the health of an identified ED depends on the level of exposure. By simply using the hazard property of a substance, such as interference with normal hormonal action, it is erroneously assumed that a substance can have a hazardous effect at any level. Moreover, there are many chemical compounds that might have an endocrine activity but without causing an adverse effect. Thus, evidence from in-vivo testing and a sufficiently established Adverse Outcome Pathway should be used for the identification of EDs.
In addition, certain aspects of the Decree remain unclear and lead to legal uncertainty:
· Legal uncertainty about the database of EDs list referred in the Decree: The French Decree refers to different lists of endocrine disruptors (proven, presumed, suspected) which shall be set up by the national risk assessment body ANSES (French Agency for Food, Environmental and Occupational Health & Safety). We are not aware of these lists being publicly available. Which substances will be in the list? How will be those lists set? How would this database be updated? We believe these points require further clarification.
· Legal uncertainty about substances not intentionally added or no longer present in the products: As currently worded, there is an ambiguity whether the French provisions cover only substances intentionally added and still present in the finished product, or also substances not intentionally added or no longer present in the products (see Groups concerned: “Anyone who markets products intended for consumers which, at the end of the manufacturing process, contain substances” and Notice “The objective restated 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 any person placing on the market products containing substances exhibiting endocrine-disrupting properties according to ANSES shall publish a list of these products and the substances that each of them contains” “This provision is part of this approach and aims to provide citizens with transparent information on the presence of substances with endocrine-disrupting properties in products, in the sense of substances, mixtures, articles and foodstuff”). To ensure legal certainty, only substances “intentionally added and still present in the finished product” should be in scope and this should be explicitly clarified in the Decree.
· Legal uncertainty regarding thresholds: A threshold is absolutely needed to ensure a common understanding of the measures. Therefore, the information to consumers on the presence of an ED should be consistent with the threshold set by REACH about the presence of SVHC – i.e. 0,1% weight in an article (article 33.2 of REACH), or between 0,1% and 1% weight in a mix (provisions in REACH about Safety Data Sheets). Without a threshold, the detection of the ED would depend on the limit of detection of the analytical methods used, which are not harmonized nor official, therefore would create unequal constraints.
· Legal uncertainty about the responsibilities and sanctions for food business operators: We would like to also emphasise that, given the key uncertainties regarding the provisions of the French Decree and the fact that there are no ED lists available yet, it is currently not possible to estimate the impact of the Decree on food business operators. Also, it is expected that it would not always be possible to gather the requested information on ED. E.g., what is about imported products or products where the French operators is dependent on suppliers located in other countries where the information is not required?
In summary, we are deeply concerned about the barrier to trade created by the French Decree, which is also neither based on scientific evidence nor enforceable without causing disruption of the Single Market. Moreover, there are already relevant activities happening at EU level, mainly stemming from the ‘Chemicals Strategy for Sustainability’ and other relevant work performed by EFSA and ECHA. We believe that the activities developed at EU level are inclusive and already addressing the current challenges on EDs, and hence no national specific legislation is needed.
We therefore ask the EU authorities to take action and disapprove the French Decree by issuing a detailed opinion.
Comments on the TRIS Notification 2020/832/F (France) - Decree on the provision of information to identify endocrine disruptors (ED)
The UK Flavour Association represents the flavouring industry in the UK. The EU is a key trading partner for our industry and several of our members are multi-nationals with branches in Europe.
We would like to raise our concerns on the French regulation, TRIS Notification 2020/832/F - Decree on the provision of information to identify endocrine disruptors in a product, which we believe diverts from the mandate already established by the EU’s “Chemicals Strategy for Sustainability” published on 14 October 2020.
We have the following concerns:
Disruption of single market
The French Decree threatens the competitiveness of the industries that have to fulfil regulations that are implemented differently in each member state, the labelling of products having to comply to a specific national regulation (and costs associated with) and the transport of goods with different specifications. This will certainly cause additional costs and burdens and uncertainty for operators and consumers.
European harmonisation on definitions
A transversal definition of endocrine disruptors (EDs) and the scientific criteria applicable are currently part of the EU “Chemicals Strategy for Sustainability”. Thus, we strongly believe that the French decree should align to European regulatory and scientific principles.
European harmonisation on communication principles
Only the substances listed as SVHC (Substances of Very High Concern) can be communicated to the public, when these are proven, presumed or suspected EDs. In the current legislation only SVHC have a traceability requirement along the supply chain at EU level. This provision allows the information to be available to all operators.
• Proven and presumed EDs: to be consistent with the EU regulation, the communication should be restricted to the substances on the list of SVHC.
• Suspected EDs: the communication should only be possible for those listed as SVHC because of any other characteristic not related to endocrine disruption.
The classification as EDs must be based on sound science and validated by independent competent bodies at European level. We believe that ECHA/EFSA should be the reference authority for EDs. This is highly important especially if the presence of EDs is communicated to consumers. The risk to the health of an identified ED depends on the level of exposure. By simply using the hazard property of a substance, such as interference with normal hormonal action, it is erroneously assumed that a substance can have a hazardous effect at any level. Moreover, there are many chemical compounds that might be Endocrine Active Substances but without causing an adverse effect. Thus, evidence from testing and a sufficiently established Adverse Outcome Pathway should be used for the identification of EDs.
Legal uncertainty about substances not intentionally added or no longer present in the products
The provision “and other relevant criteria” is not precise enough and subject to interpretation. To avoid legal uncertainty, only substances “intentionally added and still present in the finished product” should be in scope and we therefore request that this is clarified in the provision.
A threshold is absolutely needed to ensure regulatory compliance and control. Therefore, the information to consumers on the presence of an ED should be consistent with the threshold set by REACH about the presence of SVHC – i.e. 0,1% weight in an article (article 33.2 of REACH). Such a threshold would enable the implementation and control of the decree. Without a threshold, the detection of the ED would depend on the limit of detection of the analytical methods used, which are not harmonized nor official, therefore would create unequal constraints.
Communication to consumers
Direct information to consumers about the presence of EDs in products does not align with the principles set by the EU “Chemicals Strategy for Sustainability” upon which only sufficient and appropriate information should be provided to the authorities to allow the identification of the endocrine disruptors to enable their management. The average consumer lacks the needed expertise to understand the complex concepts of “suspected, presumed or confirmed”. This makes it difficult for them to make decisions about a health hazard based only on the information of the lists of substances present. Regulated substances are authorised for use only when they are deemed safe based on the scientific evidence available. We consider that regulating the use of EDs and managing the risk are the responsibility of the authorities and this responsibility should not be delegated to consumers.