§ Lord Stoddart of Swindonasked Her Majesty's Government:
Whether they have sought the modification of the data requirements of the draft Biocidal Products Directive; with what result; and whether any modification which has been made will reduce the registration costs which would arise as a result of the implementation of the directive. [HL1608]
§ Baroness HaymanThroughout the negotiations of the Biocidal Products Directive, the Health and Safety Executive (HSE), who led negotiations for the United Kingdom, sought to ensure that the cost provisions of the directive were proportionate to risk. The UK was successful in introducing simplified procedures for dealing with low risk products and for handling "frame formulation"—i.e. specifications for groups of similar products. These will help to reduce costs.
The UK was also successful in ensuring that an "escape" clause was written into the directive to minimise the data requirements. This provides that information not necessary owing to the nature of a particular biocidal product or its proposed uses need not be supplied, but without compromising the risk assessment that ensures a high level of protection for humans and the environment. This will further help to reduce costs.
The Finnish authorities are currently producing guidance, under contract to the European Commission, on the application of the data requirements. The HSE is seeking to ensure that the guidance takes full account of the flexibility which the directive provides so that costs are minimised.
HSE is encouraging industry to play its part by lobbying the European Commission and other member states. HSE has discussed with industry the possibility of their forming task forces to share data to help reduce costs. HSE continues to work closely with industry over implementation of the Biocidal Products Directive. All this action taken together will help to ensure costs are kept to a minimum.
§ Lord Stoddart of Swindonasked Her Majesty's Government:
If the data proposals of the draft Biocidal Products Directive proceed, what contingency plans they have made to support or compensate firms which cannot afford to register their substances or products, including finding employment for workers displaced. [HL1609]
§ Baroness HaymanThe text of the directive has been agreed by the Council and the European Parliament. The data requirements of the directive are complex and technical guidance on their practical application is being prepared by Finland, under contract to the European Commission. The specification for the work stipulates that other member states and industry specialists must be consulted on the guidance.
The consultation process has just started. In commenting on the draft guidance produced by Finland, 55WA the Health and Safety Executive (HSE), on behalf of the United Kingdom, has underlined the importance of flexibility in data requirements. It is understood that the biocides industry—through its European trade body, CEFIC—has commented in a similar vein. HSE will be involved in subsequent negotiations and will be seeking to ensure that the guidance reflects a flexible approach. HSE will remain in close touch with industry throughout this process.
§ Lord Stoddart of Swindonasked Her Majesty's Government:
What plans they have to protect public health from the possible increase in infections and infestations that may result from any reduction in available products and substances, or the lack of availability in some areas of such products and substances, as a result of the implementation of the Biocidal Products Directive. [HL1610]
§ Baroness HaymanA primary aim of the Biocidal Products Directive, which is due to be implemented by May 2000, is to ensure that biocidal products provide a high level of protection for humans and the environment. All biocidal products on the European Union market will have to be authorised for use. In order to gain authorisation for products they wish to place on the market, companies will be required to submit data to show that the product is sufficiently effective; has no unacceptable effects on the target organisms; has no unacceptable effects itself or as a result of its residues on human or animal health; and, has no unacceptable effects itself or as a result of its residues on the environment. It will be for industry to decide which products it wishes to place on the market.
Existing products within the scope of the directive will be able to stay on the market until the active substances they contain have been reviewed under the new arrangements. The directive gives 10 years for all existing active substances to be reviewed.
Should an emergency arise which may affect public health, there are provisions in the directive for member states to grant a temporary authorisation of a biocidal product because of an unforeseen danger which cannot be contained by other means.