Biocides directive updates

It is intended to give guidance on how the documentation to be submitted by the applicant should be prepared and presented. TNsG on the assessment of technical equivalence. The TNsG on the assessment of technical equivalence guidance is intended to establish harmonised criteria and processes for assessing the equivalence of different sources of a substance versus the reference source. The EU Technical Guidance Document TGD for risk assessment of new and existing substances and biocides is the basis for risk assessment of active substances.

It focuses on methodological and procedural agreements that have been reached in the TMs. MOTA is not a legally binding document, but is intended to provide a source of information on the TM agreements with general relevance. Emission scenario documents ESDs are used to estimate the initial release of substances from biocidal products or treated materials to the environment per PT.

Manual of Decisions. Additional guidance on specific issues. Minutes of Technical Meetings. Companies are also required to provide the consumers with information about the biocidal treatment of the article they are selling. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days. The labeling of treated articles must be done according to both the Regulation on Classification, Labelling and Packaging CLP and the additional requirements in the Biocidal Products Regulation.

Note: If a treated article has a primary biocidal function, such an article needed to be authorised as a biocidal product. We do not provide consultancy services. If you have questions or need any help, please contact our sponsor. You may also find an expert in CSP business directory below.

If you are a consultant, you may get yourself listed in CSP business directory free or sponsor this page to leave your contact info on this page.. Definition of Biocidal Products and Scope The definition of biocidal active substance, biocidal products and treated article is listed as follows: Active substance : a substance or a micro-organism that has an action on or against harmful organisms. Biocidal produdcts : any substance or mixture, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

Treated article : Articles that have been treated with, or intentionally incorporating, one or more biocidal products. List of Approved Active Substances It is very important to find out if an active substance has been approved or not since only biocidal products containing approved active substances can be marked or used to treat articles.

Please see example below. List of Active Substances Suppliers Article 95 List From 1 September , a biocidal product cannot be made available on the EU market if the active substance supplier or product supplier is not included in the list of active substances suppliers article 95 list. Contec Cleanroom plans purpose-built 60, sqft facility. Virucidal testing of cleanroom disinfectants. Big names announced for leading Pharma and Cleanroom conference. Going clean and green: A recycled polyester cleanroom wipe.

Contec partners with Milliken to produce Sporicidin brand disinfectant. Cleanroom Technology Conference announces confirmed speakers. Editor's comment: Extraordinary measures. Contec specifies list of disinfectants effective against coronavirus. Challenging disinfectant residues as per GMP Annex 1. Editor's comment: Outside your comfort zone. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used subject to national laws pending the final decision on the approval of the active substance and up to 3 years after.

Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted. The BPR aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products; and introduce timelines for Member State evaluations, opinion-forming and decision-making. It also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.

As in the previous directive, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level.