Biocide producers face costly new EC approval system

The Commission has been urged by Member States for some time to harmonise authorisation procedures for the wide variety of biocidal products in use within the EC. An estimated 10,000 biocidal products and several hundred active ingredients are on sale within the Community.

A legislative proposal was finally issued in August. Many of its provisions are similar to those of the 1991 Directive on plant protection products. The Commission hopes to have the legislation implemented by the Member States 18 months after it is adopted by Ministers.

The proposal would create a positive list of authorised biocidal active ingredients to be listed in an Annex I. A substance could only be granted authorisation for a maximum of 10 years, after which its inclusion in Annex I would have to be reviewed in the light of the latest scientific and technical knowledge. A Standing Committee on Biocidal Products made up of national officials would assess applications forwarded by Member States for inclusion of active ingredients in Annex I.

Approval of biocidal products containing substances listed in Annex I would be left to Member States. Approval of a product in one Member State would open the door for marketing it in any other EC country. In certain instances other Member States would be able to attach their own conditions. But derogations from this mutual recognition procedure would be allowed only in exceptional circumstances.

The draft Directive allows for a 10-year transitional period during which Member States would be able to authorise products containing active substances that were already on the market prior to the Directive's entry into force but which had not yet been assessed for inclusion in Annex I. The intention is that active ingredients on the market when the Directive is implemented will be reviewed for inclusion in Annex I within this period, although this could prove an over-optimistic target.

As it stands, the proposal is simply a framework describing the objectives and procedures of the harmonisation exercise. The meat of the Directive will lie in the contents of its annexes, all of which have yet to be fleshed out. Annexes II and III specify the test data that would have to be submitted for each biocidal product and active ingredient respectively, while Annex IV lists supplementary test data that may be requested for particular applications of biocidal products. The types of products that would come within the scope of the Directive are listed in Annex V.

However, the strength of the Directive will lie in a set of "common principles" for product assessment. As with the Directive on plant protection products, these will be contained in a separate document which is likely to take the form of a "daughter" Directive (see below).

A draft set of common principles is being drawn up by the Danish Environmental Protection Agency under contract to the Commission. The principles will guide Member States on the scope and quality of data needed for a full assessment and specify a set of quantitative and qualitative thresholds to enable them to decide whether to approve a product or active ingredient.

In an explanatory memorandum accompanying the draft Directive, the Commission outlines the results of a review of existing national authorisation procedures. This "found that biocidal products currently have a highly diverse regulatory status in the Community that could lead to barriers to trade between Member States creating unequal conditions of competition and thereby directly affecting the establishment and functioning of the internal market. Also their production and use may entail dangers for man and the environment."

Harmonisation of the UK's current regulations for biocides with the higher standards - particularly environmental standards - in countries such as the Netherlands will undoubtedly mean a significantly increased regulatory burden for some product categories in the UK.

The Health and Safety Executive, which will lead negotiations on behalf of the UK, was able to say with confidence that only seven of the 17 product categories listed in Annex V of the draft Directive are already sufficiently regulated because they come under the Control of Pesticides Regulations 1986. These are wood and masonry preservatives, rodenticides, avicides, molluscicides, insecticides and acaricides and anti-fouling biocides.

The other categories on the EC list are disinfectants, swimming pool disinfectants, food industry disinfectants, general biocides, sanitary biocides, air-conditioning biocides, textile preservatives, consumer product preservatives, industrial biocides and specialist biocides.

It is impossible to determine the scope of these categories with any certainty at this stage, and because they are widely felt to be confusing it is possible that they will be further refined or modified. For example, the term "specialist biocides" is defined as the "control of harmful organisms in connection with specific products, substances, materials, articles on areas not covered by other product types." And according to one manufacturer of biocidal active substances, the term "consumer product preservatives" could cover a multitude of applications from paint preservatives to household detergents such as washing-up liquids.

While each of the remaining 10 categories is subject to general legislation such as that governing the introduction of new chemical substances, most of the product types - and in particular anti-bacterial substances such as disinfectants - would have to pass through a significantly extended risk assessment procedure before they could be marketed if the Directive is adopted as it stands.

In general terms, the HSE says, the additional data that would have to be submitted for the approval process is likely to relate to the fate and distribution of the active substance and product in the environment.

According to the UK Chemical Industries Association (CIA), biocide producers are generally in favour of the attempt to harmonise registration procedures, even though it notes in a position paper that the draft Directive "will require suppliers to provide substantial amounts of product and applications data on a diverse range of industrial chemicals which, the producers and industrial users contend, are unlikely to enter the food chain and to which there is minimal environmental exposures."

The CIA's estimates of the cost of complying with the data requirements are about o7 million to prepare a technical dossier for each active substance and o100,000 for each biocidal product. However, these figures must be treated with some scepticism because the precise data requirements of Annexes II, III and IV have yet to be agreed.

The CIA also has more specific problems concerning the practical implementation of the Directive. One of these concerns the transitional arrangements for the review of active substances already on the market. The concern is that producers whose substances are reviewed early on and are subsequently listed in Annex I could gain an unfair advantage against those whose substances may be reviewed some years later.

But by far the CIA's greatest concern centres on Article 9.5 of the proposal. This provides that "the inclusion of an active substance in Annex I may be refused or reviewed if there is another active substance on Annex I for the same product type, or another method of control exists, which in the light of scientific or technical knowledge presents significantly less risk to health or to the environment." Later in the clause a proviso is added to the effect that the existing alternative substance or method must be demonstrated to have the same effect on the target organism "without significant economic and practical disadvantages to the user."

This, biocide producers claim, would introduce an unacceptable fourth hurdle of "need" in addition to the safety, quality and efficacy tests that a new substance would have to pass.

A CIA spokeswoman questioned whether the authorities would read the "safeguard" clause in the latter part of Article 9.5. "I would suggest not," she said. "The sentence just should not be there. If competent authorities are sufficiently concerned that a substance poses an unacceptable risk then they simply should not allow it for reasons other than a comparative assessment with existing products."

Article 9.5 has apparently provoked some dispute within the European chemical industry. One school of opinion is that in opposing the clause the industry could lay itself open to the charge that it was contravening its own "Responsible Care" principles, which strive for the highest practicable safety and environmental standards.

However, the CIA is sticking to the line that the risk assessment provisions in the biocides Directive should suffice to prove that a substance does not pose an unacceptable risk, and that any comparisons with other products are therefore superfluous and contrary to the Community's free trade regime.