Revised Note for Guidance on Treated Articles Agreed by EU Biocides Authorities

Original Article from CIRS

The authorities in member states of European Union unanimously agreed the revised note for guidance on treated articles under the biocidal products regulations (BPR) in the meeting last week. It is reported that the ultimate comments on the note is planned to be published before November 21st, and the final edition of the guidance will be issued by European Commission in not-so-long future.

The amended note for the guidance defines that the treated articles’ stipulation application hinges on whether products “deliberately contain” a biocidal component. In other words, if a biocidal component has sustained effect on the article or if the product is “treated with” biocidal products, then the provisions should apply. The phrase “treated with” means that the effect of a biocidal component is short-term, which does not provide protection in the long run.

The revised note makes it clear that mixtures, made up of different ingredients, will usually be exempted from the provisions of BPR. But the provisions will surely be implemented if a mixture has one or more kinds of components that contain a biocidal product, which makes the finished products possess biocidal property.

The way for the approval of active substances was also agreed by authorities of member states. A file issued a couple of days ago requires that the approval of an active substance should not refer to the precursors that generate it, when more than one kind of precursors are involved.

European Commission pointed out that the active substances should be defined by the precursors, supported in dossier. By doing this, it will not only change the definition of some substances, but also add more entries into the review programmes.

The commission and the member states competent authorities used to make a collection of agreements. But the announcement made in the last week’s meeting indicated that these agreements were abolished for the better implementation of BPR, and some other documents were endorsed, which include:

  • the classification and labelling of anticoagulant rodenticides;
  • the application of the substitution criteria;
  • procedures related to the examination of the exclusion criteria and conditions for derogation;
  • implementing the new concept of biocidal product families, as based on the updated provisions of the BPR;
  • whether disinfectants for mucous membranes are biocidal products, covered by the definition of product-type one;
  • a proposed human health assessment scheme for the authorisation of biocidal products, containing substances of concern; and
  • the application of the provisions of Article 56 on research and development.

For more documents, you can find on the EU website for communication and information or download revised note for guidance.

Bonus!

CIRS and Eurofins plan to launch the 2015 BPR training seminar in Hangzhou. There will be experts from Europe and China attending the seminar to give profound analysis for EU BPR and introduce practical regulatory compliance experience. Want to know more about the seminar? Just click here.

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