ED-relevant Legislations

More than 40 different legislations are involved in the regulation of chemicals in the EU. A short description of the jurisdictions most relevant to regulation of endocrine disrupting chemicals, as well as the procedures, are given here.

REACH

Responsible body: ECHA (European Chemical Agency)

Jurisdiction: REACH regulates industrial chemicals produced in, or imported into the EU.

Procedure: If a Member State or ECHA has a concern due to endocrine disrupting properties of a compound they can nominate it as a SVHC (Substance of Very High Concern) according to Article 57(f) in the REACH regulation. After a public commenting round the proposal is referred to the Member State Committee (MSC) for agreement seeking. If the MSC reaches a unanimous decision, the compound is included on the Candidate List of substances of very high concern for Authorisation due to endocrine disrupting properties. If the countries in MSC do not agree, the proposal is referred to the European Commission for a final decision.

In order to be included on the Candidate List of substances of very high concern for Authorisation due to endocrine disrupting properties the compound has to be of equivalent level of concern (ELoC) to one of the other article 57 SVHC concerns, i.e. carcinogenicity.

Inclusion on the Candidate List is only based on hazard properties of the compound. Risk-related factors like uses, exposures, emissions etc. are not considered for the listing.

ECHA regularly assesses the substances from the Candidate List to decide which ones should be included in the Authorisation List as a priority.

Regulatory consequences: When a substance on the Candidate list is present in an article, the suppliers of the article has an obligation to inform downstream users and to inform citizens upon request. The producer or importer of the article has an obligation to notify the ECHA.

Following inclusion on the Authorisation List, each specific use of the substance is bound to the granting of a temporary and renewable authorisation.

 

Pesticides (Plant Protection Products - PPP)

Responsible body: EFSA (European Food Safety Authority)

Jurisdiction: The legislation (Regulation (EC) 1107/2009) regulates active substances used in plant protection products to protect crops against pests or weeds, i.a. primarily in agriculture.

Procedure:

Plant Protection Products (PPP) cannot be authorised for placing on the market and for use without prior approval of their active substance(s).

The approval period of an active substance is maximum 15 years after which an application for renewal of the approval must be submitted. The approval is based on a set of mandatory studies of the substance’s toxicology, physical and chemical properties, residues in food and feed, behaviour in the environment and effects on non-target organisms in the environment, as well as on scientific information from the open literature.

Active substances are generally not approved if they are classified as carcinogenic, mutagenic, toxic to reproduction or, since October 2018, if they are deemed endocrine disrupting substances according to the scientific criteria laid down in Commission Regulation (EU) 2018/605. The assessment as regards the endocrine disrupting properties must be performed according to Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (EFSA/ECHA 2018). The assessment of endocrine disrupting properties is performed (together with risk assessment of the aforementioned other properties) by a rapporteur Member State (RMS). Rapporteurships are voted upon by MS in the Standing Committee of Plants, Animals Food and Feed (SCoPAFF), the proposals are drafted by the Commission and discussed with MS ahead of vote. The assessment is made when a new active substance is submitted for approval, or an existing one is submitted for renewal of approval. The RMS submits its assessment in a Draft Assessment Report to EFSA, which performs a peer review of the assessments. After a 60 day public commenting round and after an expert consultation (peer review meetings), EFSA submits a Conclusion to the Commission, which then presents a review or a renewal report and a draft regulation on (non-)approval to the Standing Committee on Plants, Animals, Food and Feed. The Committee finally votes on approval/renewal or non-approval/non-renewal of the active substance. This proposal is submitted to the EU Council and Parliament for adoption.

Once the active substance is approved, its use in PPPs is assessed at national level to determine if it is safe before its placement on the market. The authorisation is valid for a maximum of 15 years (depending on the duration of the approval of the active substances it contains) after which an application for re-authorization must be submitted. The authorisation is also built on a set of mandatory studies (toxicology, physical and chemical properties, residues in food and feed, behaviour in the environment and effects on non-target organisms) performed with the PPP.

Regulatory consequences: Active substances identified as ED are not approved unless it could be proved that the exposure, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans, and where residue levels do not exceed the default value 0.01 mg/kg, or if evidence shows that the substance is necessary to control a serious danger to plant health which cannot be contained by any other available means.

 

Biocidal Products (BP)

Responsible body: ECHA (European Chemical Agency)

Jurisdiction: The Biocidal Products Regulation (Regulation (EU) 528/2012) regulates biocidal products used to protect humans, animals and manufactured materials against harmful organisms (pests, bacteria, algae, viruses, etc.) via the active substance contained in the product.

Procedure: Biocidal products cannot be placed on the market or used without prior approval of the active substance(s) that they contain. An approval is valid for a maximum of 10 years after which an application for renewal of approval must be submitted. The approval is based on an assessment of mandatory studies of the substance’s toxicology, behaviour in the environment, effects on non-target organisms, efficacy, and on scientific information from the open literature.

Based on hazard assessments, substances are generally not approved if they fulfil certain  exclusion criteria (e.g. if they are classified as carcinogenic or identified as persistent,bioaccumulative and toxic). Since 7 June 2018, these exclusion criteria include identification as an endocrine disruptor, as defined by Commission Regulation (EU) 2017/2100. The assessment of the endocrine disrupting properties is performed according to Guidance for the identification of endocrine disruptors in the context of Regulations (EU) 528/2012 and (EC) 1107/2009 (EFSA/ECHA 2018).

The applicant shall submit an assessment of the relevant ED studies and other data available to them, including a literature study. This shall then be evaluated by an evaluating Competent Authority (eCA). This evaluation is peer-reviewed by ECHA and by the other Member States. Finally the Standing Committee on Biocidal Products votes on approval or renewal of the active substance. The substance is approved upon condition that it is efficacious according to the claims supported in the application, and does not pose unacceptable risks to human health, animal health or the environment.

Regulatory consequences: No approval of a substance if it is identified as an endocrine disruptors, unless

• The exposure of human and environment under realistic worst case conditions of use, is negligible  (e.g. use in closed system) or
•  Evidence is provided to demonstrate that the substance is essential to prevent or control a serious danger to human health, animal health or the environment or
• Not approving the substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment.
• If the substance is only shown to be ED regarding non-target organisms, the substance can be approved (for use by professionals only)

If an active substance is approved on the grounds of one of these arguments, then authorisation of biocidal products containing the active substance is strictly limited. For example, the applications are subject to both risk assessment and comparative assessment. Moreover the approval of the active substance is limited to 7 years, and authorization of biocidal products is limited to 5 years. Products may not be authorised for use by the public. The ED effects should also qualify as a “major concern”, so that restrictions on the treatment of articles should also be imposed at active substance approval.

 

Cosmetics

Responsible body: SCCS (Scientific Committee on Consumer Safety)

Jurisdiction: Any substance or mixture intended to be placed in contact with the human body with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours

Procedure: Cosmetics ingredients are regulated by Regulation (EC) No 1223/2009 and through the Annexes II-VI.

Annex II and III contains lists of substances that are prohibited or restricted respectively for use in cosmetics products.

Annex IV (colourants), V (preservatives) and VI (UV-filters) are positive-lists of substances within the respective use groups which are approved for use in cosmetics products.

The safety-in-use of cosmetic products is established by controlling the safety of the ingredients. Since July 2013, Regulation (EC) No 1223/2009 applies for cosmetic products. For those ingredients for which some concern exists with respect to human health (e.g. colourants, preservatives, UV-filters, hair dyes), safety evaluation is done at the Commission level by the Scientific Committee on Consumer Safety (SCCS). These substances are addressed in the Annexes of Regulation (EC) No 1223/2009. For the safety evaluation of cosmetic ingredients, all available scientific data are considered, taking into account the testing and marketing bans in force under Regulation (EC) No 1223/2009. An Opinion is handed in to the Commission (DG Growth) where possible Risk Management Actions are considered.

On 7 November 2018, the Commission adopted a review^[1] of Regulation (EC) No 1223/2009 on cosmetic products (‘Cosmetics Regulation’) regarding substances with endocrine disrupting properties. The Cosmetics Regulation does not have specific provisions on EDs. However, it provides a regulatory framework with a view to ensuring a high level of protection of human health. Environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No 1907/2006 (‘REACH Regulation’).

In the review, the Commission commits to establishing a priority list of potential EDs not already covered by bans or restrictions in the Cosmetics Regulation for their subsequent safety assessment. A priority list of 28 potential EDs in cosmetics was consolidated in early 2019 based on input provided through a stakeholder consultation. The Commission then organised a public call for data from 16 May 2019 – 15 October 2019 on 14^[2]of 28 substances (to be treated with higher priority) in order to be able to prepare the safety assessment of these substances.  SCCS will be mandated to assess the safety of the prioritized ingredients taking into account their ED properties.