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The Biocidal Products Committee adopts 8 opinions
ECHA/NA/14/53
The fields of application include active substances for use in biocidal products used as insecticides, wood preservatives, fungicides and disinfectants. In addition the BPC confirmed the status of piperonyl butoxide (PBO) as an active substance.
Helsinki, 9 December 2014 – The Biocidal Products Committee (BPC) met for the eighth time from 2 to 5 December 2014. The adopted opinions concern, and support the approval of, the following active substances and their product-types (PTs):
Hexaflumuron is an existing active substance evaluated in PT 18. Biocidal products containing hexaflumuron are intended for termite control by professionals.
The BPC confirmed that hexaflumuron is a candidate for substitution because it is very persistent, very bioaccumulative and toxic.
The evaluating competent authority of the active substance application is Portugal.
3-iodo-2-propynyl butyl carbamate (IPBC) is an existing active substance evaluated in PT 13.
IPBC is a preservative in metalworking fluids intended to be used only in professional applications to control the growth of fungi. Metalworking fluids are used to cool, lubricate and flush away metal shavings during the manufacturing of metal products.
The evaluating competent authority of the active substance application is Denmark.
Propiconazole is an existing active substance evaluated in PT 7.
Propiconazole is used by both professionals and non-professionals as a film preservative. Propiconazole protects paints or adhesive films against fungal infestation. The biocidal products containing propiconazole are applied by brushing, rolling or spraying. As an adhesive, propiconazole is used in tile glues.
The evaluating competent authority of the active substance application is Finland.
5-Chloro-2-(4-chlorophenoxy)-phenol (DCPP) is an existing active substance evaluated in PTs 1, 2 and 4. For PT 1, DCPP is used as a bactericidal active substance for use in liquid soap formulations for hand disinfection. PT 2 products containing DCPP are intended to be used as surface disinfectants and PT 4 DCPP is intended to be used in dishwashing liquids.
The BPC confirmed that DCPP is a candidate for substitution by being a substance for which two of the three PBT criteria are met (the metabolite methyl-DCPP fulfils the T-criterion and the vB-criterion).
The evaluating competent authority of the active substance application is Austria.
Potassium sorbate is an existing active substance evaluated in PT 8. Potassium sorbate is used by professionals as a wood preservative for freshly cut wood. Target organisms are fungi that cause wood staining, mould and storage rot.
The evaluating competent authority of the active substance application is Germany.
Pythium oligandrum M1 is a naturally occurring parasitic fungus and an existing microbial active substance evaluated in PT 10, construction material preservatives. It is a fungicide intended to control moulds on masonry for both curative and preventive treatment.
The evaluating competent authority of the active substance application is the Czech Republic.
Piperonyl butoxide (PBO) for PT 18
In addition, the BPC discussed the status of piperonyl butoxide (PBO) under the Review Programme. The BPC confirmed the outcome of discussions from the BPC Working Group on Efficacy, namely that PBO is considered as an active substance. The Commission will consider further the implications of this conclusion at the next Biocides CA meeting and liaise with the relevant bodies of the regulatory framework for pesticides. In parallel, the peer review of PBO will be initiated by the evaluating competent authority Greece.
Further information
The opinions will be available at the following link in the near future:
Background Information
The role of BPC in EU regulatory processes
The Biocidal Products Committee prepares the opinions of the Agency related to several processes under the Biocidal Products Regulation. Each EU Member State is entitled to appoint one member to the BPC for a renewable term of three years.
In relation to applications for the approval of new active substances, companies have to apply for approval of an active substance by submitting a dossier. After a validation check, the evaluating competent authority carries out an evaluation within one year. The result of the evaluation is forwarded to the BPC, which prepares an opinion within 270 days. The opinion serves as a basis for decision-making by the European Commission and the Member States. The approval of an active substance is granted for a defined number of years, not exceeding 10 years.
Substances which were on the market before 14 May 2000 and are evaluated under the biocides review programme in an analogous manner to new active substances, are referred to as existing active substances.
During the approval process of an active substance, the evaluating competent authority may conclude that the active substance meets the criteria for substitution of Article 10(1) of the BPR and is therefore a potential candidate for substitution. The objective of this provision is to identify substances of particular concern to public health or the environment and to make sure that these substances are phased-out and replaced by more suitable alternatives over time. The criteria for substitution are based on the intrinsic hazardous properties in combination with the use and include, for example, if the substance meets at least one of the exclusion criteria listed in the BPR or if the substance is a respiratory sensitiser.
For substances that are identified by the evaluating competent authority as a potential candidate for substitution, ECHA will initiate a public consultation to allow interested third parties to submit relevant information, including information on available substitutes. Subsequently, in the preparation of its opinion, the BPC reviews the proposed identification of the active substance as a candidate for substitution. Active substances which are candidates for substitution will not be approved for more than seven years, even in the case of renewal. If the active substance meets one or more exclusion criteria, it will only be approved for five years. When an active substance is identified as a candidate for substitution, products containing that active substance will have to be subject to a comparative assessment at the time of authorisation and will only be authorised if there are no better alternatives.