Documents considered by the Committee on 20 July 2016 Contents

4Endocrine disruptors in plant protection and biocidal products

Committee’s assessment

Politically important

Committee’s decision

Not cleared from scrutiny; further information requested

Document details

Commission Communication on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of EU legislation on plant protection products and biocidal products

Legal base

Department

Environment, Food and Rural Affairs

Document Numbers

(37880), 10442/16 + ADDs 1–17, COM(16) 350

Summary and Committee’s conclusions

4.1Because biocidal and plant protection products used to control harmful or unwanted organisms can in turn have harmful effects themselves, their use is controlled by EU legislation aimed at reducing any hazard to human health, animals or the environment. Although most of the hazard criteria are well established, this is not the case for endocrine disrupting chemicals (EDCs) which have the potential to affect hormonal systems, and the relevant legislation was adopted with interim criteria to identify EDCs, the Commission being given the task of establishing definitive criteria by December 2013. Since then, there has been considerable scientific and political debate on the criteria to determine what constitutes an EDC, and the Commission has only now produced this Communication explaining its approach to this issue, including the one which it has taken in two draft Regulations it has prepared setting out scientific criteria for determining endocrine disrupting properties.

4.2The Government says that it will carefully consider the detail of the Commission’s proposals and their impact on the transitional arrangements, including the approval of applications already submitted, and that it will also be consulting UK stakeholders. In the meantime, it notes that the two legislative proposals essentially involve developing hazard criteria—an approach to which the UK is opposed, on the grounds that the protection of health and the environment can be fully achieved through risk assessment, which would have a smaller economic impact since it would allow the use of hazardous substances posing a low risk.

4.3As is evident from the time it has taken the Commission to produce this Communication, this is a complex subject, giving rise to a number of difficult and esoteric issues, and we therefore think it right to draw the document to the attention of the House. We also think it would be right to hold it under scrutiny, pending further views from the Government in the light of its more detailed consideration and consultation with stakeholders.

Full details of the documents

Commission Communication on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of EU legislation on plant protection products and biocidal products: (37880), 10442/16 + ADDs 1–17, COM(16) 350.

Background

4.4Although both biocidal and plant protection products control harmful or unwanted organisms through chemical or biological means, they can in turn have harmful effects themselves, and their use is therefore controlled by EU legislation—notably the Biocidal Products Regulation (EU No. 528/2012) and the Plant Protection Products Regulation (EC No. 1107/2009)—which contain important safeguards to ensure that they can be used without causing unnecessary harm to human health, animals or the environment.

4.5Each Regulation operates in two stages. “Active substances” are first assessed at EU level for their efficacy and any potential risks they might pose to human health, animals or the environment: and, where an active substance (some of which may have uses under both regimes) passes that assessment, companies can then apply for a formulated product containing it to be authorised. Each Regulation also provides that active substances presenting certain types of hazard are not normally allowed for use in products, although there some exceptions, those under the biocides legislation being relatively broad (and based on negligible risk, essential use or socio-economic considerations), whilst those under plant protection products legislation are a good deal narrower (allowing exceptions based on “negligible exposure” or, in certain situations and under strict conditions, a serious danger to plant health).

4.6Most of the hazard criteria—for example, those for carcinogenicity—are well­ established. However, this is not the case for endocrine disrupting chemicals (EDCs) which have the potential to affect hormonal systems, and both the Biocidal Products Regulation and the Plant Protection Products Regulation were adopted with interim criteria to identify EDCs, with the Commission being given the task of establishing definitive criteria by December 2013.

4.7Since then, there has been considerable scientific and political debate on the criteria to determine what constitutes an EDC, including the question of a “safe threshold” and how this can be established. The slow progress made by the Commission has been criticised by some Member States, and was the subject of a legal action16 by Sweden, leading to a declaration from the General Court in December 2015 that the Commission had failed to act on its obligations under Biocidal Products Regulation.

The current document

4.8The Commission has now produced this Communication explaining its approach to this issue, including the one which it has taken in two draft Regulations17 it has prepared setting out scientific criteria for determining endocrine disrupting properties in the context of Regulations (EU) No. 528/2012 and (EC) No. 1107/2009.

4.9More specifically, whereas interim criteria have defined the endocrine toxicity of chemical substances by reference to their potential effects on endocrine organs, the draft scientific criteria now being presented by the Commission aim to repIace these with reference to adverse health caused by an “endocrine mode of action”. In other words, a substance will be considered an EDC if it works through the endocrine system to have a health impact. The Commission has also concluded that it will define an “adverse effect” in the terms used by the International Programme on Chemical Safety as a “change in the morphology, physiology, growth, development, reproduction, or, life span of an organism, system, or (sub) population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences”.

4.10At the same time, however, although endocrine disrupting substances would continue to be banned under both plant protection legislation and biocides legislation on the basis of hazard, the Commission has looked at the basis on which exemptions might be allowed, and, in the former case, it has suggested that these could in future be updated so as to refer—as is already the case for biocidal products—to negligible risk, as opposed to negligible exposure.

The Government’s view

4.11In his Explanatory Memorandum of 5 July 2016, the Minister of State for Farming, Food and the Marine Environment (George Eustice) says that the Government will carefully consider the detail of the Commission’s proposals and their impact (which are likely to differ as between biocides and for plant protection products because of differences in the primary legislation). He also says that it will be important to clarify the transitional arrangements for, and impact on, the extensive review programmes for both class of product in relation to applications already submitted by industry, where the Commission has indicated that the new arrangements will apply to applications for approval which are already being assessed, without a transitional period.

4.12In the meantime, he notes that the two legislative proposals essentially involve developing hazard criteria—an approach which the UK has consistently opposed, not least in the adoption of Regulation (EC) No. 1107/2009, believing that the protection of health and the environment can be fully achieved through risk assessment, which would have a smaller economic impact in that it would allow the use of hazardous substances posing a low risk. He also notes the considerable economic importance of the choice of criteria with a hazard-based approach, since this could have a significant effect on the availability of effective products.

4.13The Minister says that the Government will seek views of UK stakeholders, including those manufacturing and supplying plant protection and biocidal products; those using them in primary and secondary production; the food processing, supply and retail industries; consumer, health and environmental organisations. In the meantime, he comments that the extensive impact assessment provided by the Commission examining the possible consequences of different criteria to identify endocrine disruptors is based on a preliminary screening of active substances approved for plant protection products and biocides for which information was available at EU level, and does not constitute an evaluation of individual substances under the respective legislation.

4.14He also says that:

Previous Committee Reports

None.


16 Case T-521/14.

17 In the former case, the amendment would be made via a delegated act under the procedure set out in Article 290 TFEU, whilst the latter would involve the amendment of “non-essential” elements of the Regulation in accordance with the regulatory procedure with scrutiny.




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25 July 2016