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Re: ENVI Exchange of Views on Biocides Regulation

To: ENVI Committee

Re: ENVI Exchange of Views on Biocides Regulation

Brussels, 4 November 2009

Dear Members of the ENVI Committee,

In preparation of your exchange of views this afternoon on the Commission’s Proposal for the “Placing on the market and use of biocidal products”, the Health and Environment Alliance would like to present some remarks for your consideration.

As an environment and health network bringing together over sixty different organisations across Europe, the Health and Environment Alliance (HEAL) welcomes the legislative initiative to improve the existing framework for the approval and use of biocides. However, we are very concerned that the current Commission proposal compromises the goal of ensuring a high level of protection for human health and the environment.

We therefore urge you to strengthen the Commission’s proposal towards better protection of human health and the environment by considering our recommendations below.

There is increasing scientific evidence pointing to the detrimental health effects of chemicals, including biocides. Because biocides are intended to kill living organisms, many biocidal products pose significant risk to human health. The use of biocides can also have significant adverse effects on the natural environment. The European Union has just passed the so-called pesticide package, with crucial new rules to phase out the most problematic pesticides, including those which play a role in the cancer pandemic and growing fertility problems. The proposal for the Biocides regulation must ensure coherence with the Pesticide legislation, and must not fall behind the important provisions for the protection of human health which have been agreed on. Better policy coherence is also needed with other EU environmental legislation (for example Water Policy) and the EU Action Plan on Environment and Health to ensure that the new biocides legislation also contributes to the overarching goal of reducing the environmental burden of disease.

HEAL calls on you to ensure the following:

-* Better health protection, precautionary principle

Many biocides are substances which can have harmful effects on human health and the environment. All decisions on the approval of such hazardous substances should therefore be based on the precautionary principle, in order to ensure there are no adverse effects on health and environment. Furthermore, the regulation should state as leading principle better health and environment protection. Both precautionary principle and better protection should explicitly be included in the subject matter of the regulation (article 1).

-* Protect vulnerable groups

Pregnant women or children are especially vulnerable to harmful effects of biocides. Their needs and specific situation have to be considered when assessing and authorizing biocides. Therefore, the regulation should make explicit reference to vulnerable groups (for example in risk assessment).

-* Comprehensive cut-off criteria, no derogations We welcome the cut-off approach for certain hazardous substances, which mirrors the approach of the pesticide regulation and is in line with the precautionary principle. These proposed exclusion criteria should be further strengthened to reflect the advances made in the pesticides regulation.

We fear that the suggested derogations compromise the goal of better health protection, creating loopholes for leaving hazardous substances on the market. We therefore urge you to support strict and stringent cut-off criteria.

-* Clear provisions for nanomaterials in biocides

In a growing number of biocidal products and applications, nano silver is being used because of its disinfectant qualities. Nano silver can now be found in washing machines, wound dressings and many other consumer and hospital products. These products are on the European market, despite scientific uncertainties about their risks for human health and the environment. The biocides regulation should specifically address nanomaterials, as being called for in a recent European Parliament resolution (P6_TA(2009)0328). Thus, specific provisions for nanomaterials should be included to ensure adequate safety evaluation, but also clear labeling rules.

Please do not hesitate to contact me should you have any questions,

Yours faithfully,


Anne Stauffer, Policy Manager

Health & Environment Alliance (HEAL), 28 Boulevard Charlemagne, B-1000 Brussels

Last updated on 13 June 2011

About HEAL

The Health and Environment Alliance (HEAL) is a leading European not-for-profit organisation addressing how the environment affects health in the European Union (EU). We demonstrate how policy changes can help protect health and enhance people’s quality of life. Read more »


HEAL has over 70 member organisations, representing health professionals, not-for-profit health insurers, doctors, nurses, cancer and asthma groups, citizens, women’s groups, youth groups, environmental NGOs, scientists and public health institutes. Members include international and Europe-wide organisations, as well as national and local groups. Read more »

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