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The Biocidal Products Committee adopts 10 opinions

ECHA/NA/14/45

The fields of application include active substances for use in biocidal products used as disinfectants, preservatives and insecticides.

Helsinki, 6 October 2014 – The Biocidal Products Committee (BPC) met for the seventh time from 30 September to 3 October 2014. The adopted opinions concern, and support the approval of, the following active substances and their product-types (PTs):

Glutaraldehyde for PTs 2, 3, 4, 6, 11 and 12

Glutaraldehyde is an existing active substance evaluated in PT 2, 3, 4, 6, 11 and 12.

Biocidal products containing glutaraldehyde are intended to be used for surface disinfection in hospitals and industrial areas (PT 2), in poultry and pig farm disinfection (PT 3), in food vessel/machinery and food processing surface disinfection (PT 4), in preservatives for detergents and paper wet-end additives, in paper coatings preservation and as a preservative for drilling and cementing muds/fluids (PT 6), in open and closed recirculating cooling systems and in preservatives for oilfield injection water and hydrotesting water (PT 11), in slimicides for paper pulp in wet-end slimicides and in paper de-inking (PT 12).

The BPC confirmed that glutaraldehyde is a candidate for substitution by being classified as a respiratory sensitiser.

The evaluating competent authority of the active substance application is Finland.

Clothianidin for PT 18

Clothianidin is an existing active substance evaluated in PT 18. Biocidal products containing clothianidin are intended for use in paint-on formulations for controlling insects such as house flies in animal housings and for domestic premises by non-professional users.

The BPC confirmed that clothianidin is a candidate for substitution because it is very persistent and toxic.

The evaluating competent authority of the active substance application is Germany.

MIT for PT 13

2-Methylisothiazol-3(2H)-one (MIT) is an existing active substance evaluated in PT 13.

MIT is a preservative in metalworking fluids intended to be used only in professional applications to control the growth of a variety of microorganisms. Metalworking fluids are used to cool, lubricate and flush away metal shavings during the manufacturing of metal products. The biocidal product containing MIT is added directly to the sump of a metalworking operation to prevent contact with the active substance which has skin sensitising properties.

The evaluating competent authority of the active substance application is Slovenia.

MBM for PTs 6 and 13

N,N'-Methylenebismorpholine (MBM) is an existing active substance evaluated in PTs 6 and 13. MBM belongs to the group of formaldehyde-releaser substances. Biocidal products containing MBM are used as bactericides for the preservation of fuels (PT 6) and the preservation of metalworking fluids (PT 13) which are prone to bacterial decay.

The PT 6 product is intended to be incorporated by industrial users into fuels during the formulation process where risk mitigation measures prevent toxic levels of exposure to the active substance or the released formaldehyde. The PT 13 product is intended to be incorporated by professional users into water-based metalworking fluids.

MBM is proposed to be classified as a carcinogen 1B therefore the BPC has confirmed that MBM is a candidate for substitution.

The evaluating competent authority of the active substance application is Austria.

Further information

The opinions will be available at the following link in the near future:

Biocidal Products Committee

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.