On 12 June 2009, the European Commission presented a proposal for a Regulation which aims at significantly increasing the safety of biocide products used and placed on the market in the EU. The future Regulation will phase out the most hazardous substances, particularly those that may cause cancer, and will introduce new rules for articles such as furniture and textiles treated with biocides, which are not covered by existing legislation. Several Hong Kong and mainland traders are thus likely to be particularly affected by the future rules.

Biocides are used to suppress organisms such as pests and germs (i.e., moulds and bacteria) that are harmful to human or animal health, and include insect repellents, disinfectants and industrial chemicals such as anti-fouling paints for ships and material preservatives. The proposed Regulation revises the 1998 Directive on biocides (Directive 98/8/EC) and addresses a number of weaknesses that were identified during its implementation. It aims at further reducing the risks posed by biocidal products and now extends the scope of the legislation also to devices which produce biocides and to biocides in materials that might come in contact with food.

The proposal introduces new criteria to prevent the use of the most hazardous active substances, particularly if they cause cancer or fertility problems, and replaces them with safer alternatives wherever possible. Products containing identified substances of high concern will be subject to comparative assessment so that the products with the highest risk will be eliminated and only the safer products will remain on the market.

As touched on above, the new rules will also apply to articles that have been treated with biocides, for example to preserve the quality and function of furniture and clothing; such articles may only be treated with authorised biocides. Treated articles will have to be labelled with warnings so that consumer are able to make an informed choice and so as to protect children and allergy sufferers, where there is a risk.

To promote the use of low-risk biocides and newly discovered substances, the Commission is proposing their authorisation at EU level. This centralised authorisation should ensure that such products are more easily available throughout the entire EU market. The European Chemicals Agency (ECHA), which - as Hong Kong traders will easily recall - is already responsible for managing REACH, will carry out scientific and technical tasks related to this type of authorisation. Most biocidal products will, however, continue to be authorised by Member States.

The proposal will turn the existing Directive on biocides into a Regulation. Thus, no transposition into national law will be required, as regulations are directly applicable in all the Member States. The new Regulation will then repeal and replace the current Directive.

The new proposal, once entered into force as a Regulation, is aimed also at reducing tests on animals. Under the new rules, tests on animals may only be conducted once. As is already the case with REACH, companies requesting authorisation will be required to share results of animal tests in return for fair compensation. In addition, tests proving the safety and efficacy of a biocidal product will only be requested in cases of actual need.

According to official sources, compared with the existing rules, the only change involving additional costs to industry concerns the extension of the scope to treated articles and materials, such as textiles and furniture. These costs will mainly result from the inclusion of further active substances in the list of substances subject to authorisation/requirements, and compliance with the labelling obligations. Nonetheless, it is the Commission's hope that the environmental and human health benefits of extending the scope to treated articles and materials will easily outweigh the costs.

The other measures introduced by the proposal, such as improved authorisation procedures, including the Community authorisation, obligatory data sharing for vertebrate animal data and streamlining the data requirements, will, it is expected, result in significant cost savings.

The proposed legislation should enter into force in 2013, giving Hong Kong and other sellers ample time to acquaint themselves with the new restrictions. The draft text can be accessed at:

http://ec.europa.eu/environment/biocides/pdf/com_2009_267_en.pdf