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EUROPE: Publication of Endocrine disruptors criteria

On 20 April 2018 was published the Commission Regulation (EU) 2018/605 setting out the scientific criteria to identify the substances used in plant protection which are endocrine disruptors (EDs).

After the rejection of the initial regulation project by the European Parliament in October 2017, the new project taking into consideration the claims of the European Parliament (i.e. the deletion of the exemption for substances that have an ‘intended endocrine mode of action’), was voted at the PAFF meeting in December 2017.

According to the Regulation, an active substance, safener or synergist is considered as ED if (i) it shows an adverse effect in an intact organism or its progeny, (ii) it alters the function(s) of the endocrine system, and (iii) the adverse effect is a consequence of the endocrine mode of action.

The new criteria will apply from 20 October 2018 onwards, including the substances for which an assessment or a re-evaluation is ongoing. A feedback regarding the experience gained from the application of these criteria will be presented by the Commission by 20 October 2025.

As a reminder, very similar criteria will apply to biocide substances from 7 June 2018. The European Union is now the first worldwide to have strict legally binding criteria to identify EDs.

Besides, the draft technical guidance document for identifying EDs of ECHA and EFSA is currently being updated with the new criteria set. The guidance document will be available by June 2018.

 

To download: Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties.

 

See also our previous articles:

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

EUROPE: Parliament rejects criteria for endocrine disruptors

Adoption of Endocrine disruptors criteria

 

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EUROPE: Parliament rejects criteria for endocrine disruptors

On 4 October 2017, the European Parliament voted to object to the European Commission’s draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs).

The Parliament objection regards the last paragraph of the draft regulation. The criteria proposed in the draft regulation provide for an exemption, or derogation, from the scope of the criteria for identifying EDCs, for substances that have an ‘intended endocrine mode of action’ (i.e. are deliberately designed to attack an organism’s endocrine system).

The Commission regretted Parliament’s vote, reportedly stating that the derogation had been essential in getting a qualified majority among Member States to support the criteria.

Now the Commission has to withdraw the draft regulation and either submit an amended version, do no further action or submit a new draft regulation. In the meantime, the interim criteria continue to apply.

 

To be downloaded:

EU Parliament: Parliament rejects criteria for endocrine disruptors

 

Our previous articles:  

Adoption of endocrine disruptors criteria

FRANCE: List of PPPs that may contain Endocrine Disruptors (EDs)

 

Lynxee consulting’s team is at your disposal to answer your questions.

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FRANCE: List of PPPs that may contain Endocrine Disruptors (EDs)

As announced in our post dated 12th July, the list of plant protection products that may contain endocrine disruptor substances has been published in France.

The products listed are products containing one or more active substances included in the impact assessment of the European Commission as falling within the definition as proposed by the European Commission. The definition adopted is broader, including suspected endocrine disrupters, and substances for which endocrine disrupting action is “plausible”.

 

IMPORTANT: Scientific agencies have not yet conducted detailed work substance by substance to verify their endocrine character based on the definition adopted by the Member States.
Substances can therefore be withdrawn or added to this list.

 

To download:  

Liste de produits pesticides susceptibles de contenir des substances perturbatrices endocriniennes

 

Our previous article:

Adoption of Endocrine disruptors criteria

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

Adoption of Endocrine disruptors criteria

Member States representatives finally voted on July 4th in favour of the European Commission’s proposal on scientific criteria to identify endocrine disruptors in the field of plant protection products. The criteria endorsed concerning substances falling within the plant protection products legislation are based on the World Health Organisation (WHO) definition. They identify known and presumed endocrine disruptors.

The criteria will apply after a short transitional period of 6 months during which the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) – mandated by the Commission – will be finalising a joint guidance document for their implementation.A public consultation is expected in autumn.

As for pesticides and biocides, the Commission will not delay any action and will already apply the criteria to substances for which assessment or re-evaluation is undergoing or for which confirmatory data concerning endocrine properties have been requested.

The impact assessment (page 112/404), published last year, identified 26 substances potentially affected by the definition based on option 2 (WHO definition): 2,4-D, 8-hydroxyquinoline, Boscalid, Cypermethrin, Desmedipham, Fenamidone, Flubendiamide, Iprodione, Lenacil, Malathion, Mancozeb, Maneb, Metiram, Myclobutanil, Oxadiazon, Pendimethalin, Propyzamide, Spirodiclofen, Tebuconazole, Tepraloxydim, Tetraconazole, Thiophanate-methyl, Thiram, Tralkoxydim, Triflusulfuron, and Ziram.

 

At French level, in a joint press release issued by the Ministries of Ecological and Solidarity Transition, Solidarity and Health, and Agriculture and Food, the French Government announced additional National measures and a revision of the the National strategy adopted in April 2014 on endocrine disrupters.

Pending the Commission’s assessment of the provisions of the text leading to the exemption of certain substances acting as endocrine disruptors, where concerns are expressed, the Government undertakes to use the procedure laid down by EU law that allows, on the basis of scientific and technical analyses carried out at National level, to prohibit the placing on the French market of products containing these substances.

Among the measures announced, Ministers of the Ecological and Solidarity Transition, Solidarity and Health, and Agriculture and Food, will seize ANSES to conduct a risk assessment of the most widely used products containing these substances.

The list of plant protection products containing at least one substance identified by the Commission as an endocrine disruptor will be published by 14 July.

 

Our previous articles:

EUROPE: Presentation of criteria to identify endocrine disruptors

FRANCE: ANSES Opinion on the definition of endocrine disruptors

 

To download:  

SANTE-2016-12020-REV 4 – DRAFT COMMISSION REGULATION (EU) …/… of XXX amending Annex II to Regulation (EC) 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties  

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

FRANCE: ANSES Opinion on the definition of endocrine disruptors

ANSES issued an Opinion on 19 July 2016 to propose criteria for endocrine disruptors (EDs) that can be used to define the French contribution to the ongoing community discussions on this issue.

This review is based firstly on the 4 options defined by the European Commission (EC) in the roadmap on EDs subject to public consultation in 2014. And secondly, it integrates the proposal of criteria for EDs identification that the EC made public on 15 June 2016 as well as several texts proposing a draft amendment to the regulations in force concerning plant protection products and biocidal products.

As a reminder, the 4 options of the 2014 roadmap were:

  • Option 1: No policy change. No criteria are specified. The interim criteria set in the Biocidal Products and the Plant Protection Products Regulations could continue to apply;
  • Option 2: WHO/IPCS definition (hazard identification);
  • Option 3: WHO/IPCS definition and introduction of additional categories based on the different strength of evidence (cat. I, II, III);
  • Option 4: WHO/IPCS definition and inclusion of potency (hazard identification and characterisation).

ANSES considers that the current choice of the EC, only partially corresponding to option 2 leads to identify only the “known” EDs and not the “presumed” EDs. The experts regret that choice. ANSES supports Option 3 that differentiates the concepts “known” EDs, “suspected” EDs and “endocrine active substances”.

The agency also recommends the application of criteria including the weight of evidence, considering that such a system would allow the application of a single classification and a management adapted to the different regulatory frameworks according to the uses and populations.

ANSES emphasizes the need to distinguish the definition and the identification of an ED (either to human health or the environment) which should be conducted by a single body at European level (e.g. ECHA), from the approval procedures for these substances according to their use.

 

To download:

ANSES Opinion No. 2016-SA-0133 relative to “the definition of scientific criteria defining endocrine disruptors”

Draft legal act under the Plant Protection legislation

Draft legal act under the Biocidal Products legislation

European Commission – Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation (June 2014)

 

Our previous article:

Europe: Presentation of criteria to identify endocrine disruptors

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/