European Commission
DG SANTE
Danish comments as follow-up to the PAFF Committee meeting 22 June 2016 / Competent Authority meeting on Biocidal Products 22 June 2016

At the PAFF Committee meeting 22 June 2016 / Competent Authority meeting on Biocidal Products 22 June 2016, participants were invited to provide written comments by 7 July 2016 with regard to the Communication from the Commission to the European Parliament and the Council (COM(2016)350) and the draft Commission Regulations setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 (C(2016)3752 projet) / setting out scientific criteria for the determination of endocrine-disrupting properties and amending Annex II to Regulation (EC) 1107/2009 (C(2016)3751 projet)respectively, as presented by the Commission at the meetings 22 June 2016.

We appreciate that the Commission finally has presented the legally required scientific criteria for identification of endocrine disrupting properties and that we have been invited to provide comments on the draft legal text on defining criteria for identification of endocrine disrupting properties /draft legal text on defining criteria for identification of endocrine disrupting properties and further amendments. In addition to the views reflected at the meetings, further Danish comments, views and proposals are presented below.

Initially, please note that DK has a parliamentary reservation on the draft proposals. Further, we are currently analyzing whether the Commission has exceeded its mandate by introducing changes to the legal text. Therefore, our comments are provided with an overarching reservation regarding the Commission mandate.

Our comments will cover both several general issues and specific comments to the legal text and the communication as outlined in the annexes.

Three general key issues should be highlighted:

  1. Level of evidencerequired for identification of ED-propertiesis too high and not scientifically justified
  2. Lack of logic and consistency in legislation
  3. Lack of precaution

Ad 1. Level of evidence required for identification of ED-properties is too highand not scientifically justified

We welcome the use of the WHO-definition for EDs for setting scientific criteria, however, noticethat the criteria are only based on some parts of the definition,and extra requirements for fulfillment of the definition have been added. It appears that the proposal has been put together by mixing text passages from the WHO-definitions of an endocrine disruptor and for adverse effects and from the CLP-text for reproduction toxicity, omitting relevant parts of these texts, and at the same time adding further requirementswith the consequence that fulfillment of the criteria requires a very high level of proof of evidence for adverse effects relevant to humans– a level of evidence that ismuch higher than currently required for identification of substances as CMRisnot scientifically justified.

On the following specific points, the Commission’s proposal considerably limits the possibility of identifying endocrine disruptors :

  • According to the legislative texts in the PPPR and BPR substances are “considered to have endocrine disrupting properties that may cause adverse effects in humans...” where the text in the draft criteria reads “…. identified as having endocrine disrupting properties with respect to humans”… and further “.. it is known to cause and adverse effect relevant for human health”. This wording goes beyond the WHO-definition and differs from the requirements for other problematic effects/mode of actionsof being “known orpresumed”. In practice,it introduces a reverse burden of proof and will certainly limit the number of substances to be identified as EDs.
  • Section A and B 1. (1-3) state a number of absolute requirements, which are very restrictive regarding identification of EDs and would be decisive in the legal interpretation of the legislation regardless of the text in the following sections. Namely, the following parts of the text “..it is not identified as havingendocrine disrupting properties with respect to humans.. and further. ..it is known to cause an adverse effect relevant for human health….” and “.. the adverse effect relevant for …. is a consequence of the endocrine mode of action”.
  • Regarding choice of data and the weight of evidence determination that the identification should be based on,the proposal limits the possibilities compared to the requirements for identification of other problematic effects /mode of actions. Given the considerable data gaps and lack of available test data from appropriate study protocols with inclusion of ED-relevant endpoints (WHO/IPCS report, 2012), it is necessary to accept the use of all relevant scientific information, including read across, QSAR etc. in line with requirements for CMR-identification.

These comments are also relevant when it comes to the criteria dealing with non-target organisms.

According to the proposal, the level of evidence for adverse effects to identify a substance as an endocrine disruptor is higher than for identification as CMR. This requirement is scientifically unjustified. In practice, this would lead to a remarkable situation that if an ED substance- which is already classified as Rep 1B due to endocrine disrupting properties- should be identified as an endocrine disruptor,this requires in addition to evidence for an endocrine mode of action and demonstration of a plausible link between the endocrine mode of action and the adverse effects, further, that the level of evidence for the reprotoxic effects now should match a Cat 1A.

Ad 2. Lack of logic and consistency in legislation

A logical and consistent legislation is fundamental for public and commercial acceptance and for legal clarity. Many endocrine disruptors are already classified as carcinogens and toxic to reproduction.Substances identified as mutagenic, toxic to reproduction or carcinogenic are already allocated into two categories according to the level of evidence for hazardous effects/mode of action. Hence, it would be logical to apply this approach for identification of endocrine disrupting properties. This will avoid future situations where a substance is identified as carcinogenic or toxic to reproduction in category 1 or 2 due to endocrine disrupting properties, but not identified as an ED or a suspected ED.

CMR-substances are divided into categories where legislative consequences are only relevant for substances known/presumed (category 1) to cause this effect as these are covered by the cut-off criteria, this is exactly the same situation as for EDs. Hence, categorization of EDs will not affect legal uncertainty. Category 2 is used by the authorities for a stepwise assessment procedure and makes it possible to require further data from industry to further enhance the level of evidence. This stepwise approach would be even more relevant in relation to endocrine disruption as this is an area withconsiderable data gaps and lack of available test data from studies that include ED relevant endpoints as well as mode of action studies. Since identification as ED requires both evidence of endocrine mode of action and adverse effects for which only a few data are available most ED substances would be allocated to category 2.

In the Commission’s presentation of the proposal, the Commissionhas stated that the CLP has another purpose (classification) and it is not relevant to use CLP text because ED is only identification and CMR identification is based on adverse effects whereas ED is based on mode of action, which is essential for the identification. In our view there is no difference between identification of inherent properties for an endocrine disruptor, a substance toxic to reproduction and a mutagenic substance, the latter also being identified by biomarkers of mode of action solely, and not by causing specific adverse effects in humans.

Classification of substances regarding effects on the environment is based on studies of effects in individuals on growth, reproduction and survival. Yet, these effect data for individuals are used for classification to protect populations, because the same endpoints will have effect on populations. The same logic should hold for ED effects.

Criteria for endocrine disrupting properties must be horizontal to maintain a logic and consistent legislation and therefore, be suitable for implementation in relevant EU-regulation in consistency with current approaches, including for identification of substances of very high concern. A category approach is currently applied in other relevant legislations e.g. to allow for a stepwise assessment – this fact also favours criteria with categories. Omission of the possibility to identify substances that - based on current knowledge - are suspected endocrine disruptors, will both be ignoring the current scientific knowledge as well as hindering further protection of human health and environment.

Ad 3. Lack of precaution

In practice, these criteria will not lead to a higher protection of the European citizens and the environment because only few endocrine disrupting substances will be identified as endocrine disruptors and substituted as described above and this is neither in line with the intention of the regulations nor the goal of the 7th EAP of minimizing the exposure to endocrine disruptors.

The draft proposals clearly ignore scientific knowledge and the increasing scientific concern of exposure to endocrine disruptors, also raised by the 2012 WHO/IPCS state-of- the- science-of-ED report. The proposals also move away from the precautionary principle by changing the legal text from “may cause” to “known to cause” which will limit the number of substances identified. The Commission has further changed the legal text of the PPPR from negligible exposure to negligible risk and other conditions for derogations,which changes the regulation’s cut-off from a hazard-based to a risk-based approach, however, still claiming it as a hazard-based approach.

The Commission states that in practice many substances where evidence as ED is available have been already banned in the EU and that the new criteria will allow for a more accurate and up-to-date assessment. However, the Commission ignores the fact that most of the data available have been generated with test methods without inclusion of relevant ED-endpoints. This is of crucial importance when it comes to ED assessment. The Commission mentions in the communication that even though the discussion on the ED mode of action centers on the EATS- modalities, the draft measures are not limited to these hormonal systems. The Commission acknowledges that a key challenge for regulators is the availability of good scientific data and will therefore ensure that data requirements are reviewed. This is welcomed and in addition,that the Commission also commits itself to contribute to the development of OECD-guidelines so the necessary range of validated tests will be available, at the latest by 2025. No test guidelines have been developed for new emerging ED endpoints as well as most of the existing data have been generated by use of test methods without inclusion of ED relevant endpoints and finally,guideline studies are preferred by the proposals.Hence, it will be nearly impossible to ensure the appropriate protection of human health and the environmentconsidering the lack of data tested with inclusion of ED-relevant endpoints and the fact that we have to wait another ten years before the necessary test methods are available.

We also note that a “new” [1]option B is now used by the Commission to justify a change of legal text by referring to the EFSA Scientific opinion on ED.It should be emphasized that the EFSAopinion does not provide new scientific knowledge – it is just an opinion on using risk assessment that is not scientifically justified and further, the scientific committee goes beyond its mandate as it puts forward guidanceon risk management which is a policy issue and not a scientific issue. This irrelevant statement cannot be used as the scientific justification for changing the legislative text.

In addition to the three key issues described above, we would like to add somecomments concerning the general content and structure of the proposals.

The proposals include a modified WHO-definition; however, they lack the necessary qualification of data that would lead to fulfillment of the definition and the following identification of EDs.Further, large parts of the text in sections 2 of both section A and B, would be better suited for guidance documents. Also, section A and B of the proposals should be merged in order to avoid unnecessary repetition.

Specific comments on the legal textsare outlined in the attached annexes.

1

[1]the text of option B “Introduction of elements of further elements of risk assessment into sectorial legislation” as laid down by the roadmap has been changed in the impact assessment to “Adjustment of the PPP derogations in light of the current scientific knowledge”