EU / 16 February 1998 / May 2000
Directive, to be implemented by all EU Member States by transposing it into national legislation
The Directive has three aims:
Article 3.1. A biocidal product cannot be placed on the market or used in a Member State unless it is authorized. This authorization is granted on the background of a dossier supplied by the applicant. This dossier includes toxicological and ecotoxicological data. The authorization is mutually recognized in all EU Member States.
Article 5.1. A biocidal product can only be authorised if the evaluation of the dossier shows that the product has no unacceptable effect on human and animal’s health or the environment.
Article 5.2. The following products can not be authorised for use by the general public:
Products classified as toxic, very toxic, category 1 or 2 carcinogen, category 1 or 2 mutagen, toxic for reproduction category 1 or 2.
Article 7.1. The authorisation of a product is cancelled if the active substance no longer is authorised , the conditions no longer is satisfied or it is discovered that the authorisation is given on the basis of false or misleading facts.
Annex I is a list of active substances that may be used in biocidal products that are put on the market and used according to the Directives’ provisions. Since 2006 the Annex I of the Directive has been amended several times adding more substances to the List.
Annex IA. This annex is a list of active substances authorised as low-risk biocidal products. The following substances cannot be included in Annex IA (Article 10.1): Substances classified as carcinogenic, mutagenic, toxic for reproduction, sensitizing or substances that is bioaccumulative and does not readily degrade.
Substances listed in Annex I and IA can be found here.
Article 5. (i) state that an entry of an active substance in Annex I and, where relevant, IA or IB may be refused or removed, if there is another active substance on Annex I for the same product type which, in the light of scientific or technical knowledge, presents significantly less risk to health or to the environment.
When such a refusal or removal is considered, an assessment of an alternative active substance or substances shall take place to demonstrate that it can be used with similar effect on the target organism without significant economic and practical disadvantages for the user and without an increased risk.
Biocidal products that are not authorised by an EU Member States cannot be marketed or used in a Member State and therefore has to be substituted with an authorised biocidal product. If an authorisation is cancelled the product also has to be substituted. The authorisation procedure is a substitution process in itself considering the risk assessment and the criteria for authorisation.
Last update: 04.08.2011