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To: ENVI Committee
Re: NGO position on the draft Klaß report concerning the biocide regulation

To Members of the EP Committee for Environment

NGO position on the draft Klaß report concerning the biocide regulation (EP Envi Committee Meeting, 23 February 2010)

Dear Member of the ENVI Committee,

on 23 February 2010 you will consider the draft report of MEP Christa Klass (EPP) on the Commission’s proposed biocide regulation (COM (2009) 267 final). CEPTA, Grüne Liga, Health and Environment Alliance (HEAL), Fédération Inter- Environnement Wallonie, Women in Europe for a Common Future (WECF), Mouvement pour le Droit et le Respect des Générations Futures (MDRGF), Clean Air Action Group Hungary, NABU, National Movement Friends of the Earth Bulgaria, Pesticide Action Network (PAN) Germany, PAN UK and PAN Europe welcome several amendments of the draft report as they will improve the Commission’s proposal at crucial passages: requirements for water protection, new provisions regarding hazardous substances and information. Despite these positive amendments, we believe that the report is not balanced enough. It devotes too much focus on individual technical or industry-related issues rather than to significantly tackling the big challenges and open questions of the Commission’s proposal associated with the marketing and use of problematic biocides in Europe. The report’s suggestions neither effectively protect the environment and human health, nor initiate a consistent change towards the phasing-out of hazardous substances and an innovative framework for the development and application of low-risk products and other sound pest management alternatives (please see our key demands on the biocide regulation). In particular, we urge you to promote changes in the report which will ensure:

- A better protection of human health and the environment from adverse effects of biocides, particularly for vulnerable groups and biodiversity

- a strict cut-off system

- a real low-risk approach

- a clear framework for the promotion of sound alternatives

- sufficient data-requirements

- a systematic approach for the use phase

- a guarantee of public access to information

In detail, we urge you to improve the report to:

1. Better protect human health and the environment from adverse effects of biocides, particularly the health of vulnerable groups and biodiversity – amend Articles 1 and 3 On the one hand, we understand the rapporteur’s amendment 10 as an initiative to protect human and animal health and the environment in principle and at a high level. We welcome this modification as a step forward. However, the regulation should also include the goal of ensuring that human health and the environment are protected from adverse effects of biocides. This would bring the Biocides regulation in line with the chemicals legislation REACH and the recently adopted Regulation on Plant Protection Products (Regulation no. 1107/2009). Increasing scientific evidence is emerging that shows certain groups of the population such as pregnant women or children are especially vulnerable to harmful effects of chemical substances, including biocides. The Regulation on Plant Protection Products recognizes their vulnerability and ensures that their specific sensitivity is taken into account in risk assessment and authorisation. The rapporteur’s draft report on Biocides should be brought in line with these provisions. It is also important to ensure that biocides and their use do not adversely affect biodiversity and Europe’s endangered species.

2. A strict cut-off system – amend Articles 5 and 45

Although the rapporteur’s draft will include in the cut-off criteria environment-related obligations and will introduce criteria for endocrine-disrupting substances (see amendment 27), the whole approach remains insufficient. Her approach, just like the Commission proposal, would still allow cancerogenic, mutagenic and reprotoxic (CMR) substances and other highly hazardous substances on the market. We think there should not be derogations from the exclusion criteria in art. 5. Article 45 offers a sufficient framework in cases of emergency but should be also strengthened for the protection of human health and the environment. 3. A real low-risk approach – amend Articles 3, 16 and 17 Nothing has been done to close the loopholes in the concept for low-risk products in the Commission proposal. Although such products will be eligible for an EU-wide authorisation (= one-zone approach of authorisation), the new approach will significantly weaken the current provisions of the Biocidal Products Directive for low-risk products (e.g. no sufficient assessment of the relevant active ingredients as they don’t have to be approved for inclusion into Annex I, no ban on substances of concern). All substances for low-risk products should be included in Annex I (undergo risk assessment) and should be of low hazard. The absence of exposure is not enough grounds for classifying a biocide as low-risk.

4. A clear framework for the promotion of sound alternatives – amend Articles 3, 9, 21, 33, 44, 70

Instead of strengthening the substitution principle (e.g. by means of introducing mandatory substitution/phasing-out plans) and supporting efforts for the development and marketing of real low-risk products, the rapporteur’s approach is to guarantee a centralised authorisation for every kind of biocidal product even though such products can include ingredients of concern (cf. amendment 57ff). We are particularly concerned that the EU standards for risk assessment and authorisation of insecticides will be replaced with the WHO Pesticides Evaluation Scheme (WHOPES, amendment 12). WHOPES functions through the participation of representatives of governments, manufacturers of pesticides and pesticide application equipment etc. It does not meet European standards of transparency and participation. As well, insecticides can be very harmful and WHOPES does not necessarily consider environment- related issues, sound alternatives or how to protect vulnerable citizens and endangered ecosystems at regional or local level from the adverse effects of insecticides.

5. Sufficient data requirements – amend Articles 16, 19, Annex II & IV

Necessary amendments in order to strengthen the data requirements are still absent. This is problematic as the Commission’s proposed authorisation system does not sufficiently assess new active substances or products, especially on impact of their metabolites and combination effects on vulnerable groups or sustainable uses of natural resources, effects on natural drinking water sources or impacts on the biodiversity of the marine environment and groundwater dependent ecosystems. The rapporteur’s proposal can even contribute to more complicated situations as it introduces possibilities for the non-assessment of substances (amendment 46) and for further derogatory simplifications of the evaluation and authorisation procedure (e.g. amendment 67: reducing the time line for evaluating assessments).

6. A systematic approach for the use phase – amend Article 15

The already documented high number on poisoning incidents in Europe should instigate ambitious and binding efforts for the use phase (e.g. training measures, certification schemes, definition of good practice and sensitive areas). We welcome the rapporteur’s initiative to introduce measures for elucidation in order to minimise the use of biocides (amendment 94). But this should only be a part of a more systematic approach within a strategy for an integrated pest management and within national action plans. For this reason, it is necessary to initiate a framework directive for the use phase which should be established in a clear time line. Such a framework is already introduced in order to regulate the use phase of pesticides.

7. Guarantee public access to information – amend Articles 54, 55, 56, 57 and 58

All information on substances, their health and environmental impacts as well as statistics should be publicly available and regularly updated. The Commission’s proposal weakens current standards of the biocide legislation by repealing obligations for publishing implementation reports. We are also concerned that the rapporteur’s draft will establish new possibilities for data protection (amendments 83 & 85) instead of opposing the weaker implementation standards. Consequently, there is still a severe gap on transparency and a lack of requirements for sufficient reporting on the biocide market, citizen’s exposure to biocides and relevant effects on humans, animals and the environment. As well, obligations for a specific labelling of products which contain nano-biocides or which have been manufactured by means of nano-technology are still missing. Hence, consumers will be faced with an intransparent situation.

We should be most grateful if you considered our comments and recommendations.

Please do not hesitate to ask for further information.

Yours sincerely,

Pesticide Action Network Germany, Christian Schweer

Pesticide Action Network UK, Nick Mole (Policy Officer)

CEPTA - Centre for Sustainable Alternatives, Daniel Lesinsky

Women in Europe for a Common Future, Demi Theodori

Health and Environment Alliance (HEAL), Anne Stauffer

Pesticide Action Network Europe/ Clean Air Action Group, Gergely Simon (Board member)

Last updated on 13 June 2011

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