The Biocidal Products Regulation (BPR) applies to 22 product types assigned to four main groups:

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• Disinfectants for home and industrial use

• Preservatives for manufactured and natural products

• Pest control products

• Other specialist biocidal products such as antifouling agents

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Access to the market is based on a two-step procedure:

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• The active substance to be used in a biocidal product or to treat an article must be approved (assessed positively for its efficacy and safety in the relevant product type at EU level.

• The biocidal product requires an authorisation at national or EU level before it can be made available on the market or used

• If the active substance is not yet approved but is in the Review Programme, the biocidal product can be made available and used in accordance with national laws

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Arrow Regulatory have extensive experience in management of active substances and biocidal products. Please contact us for further discussion.

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Active substances

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An active substance can be used in a biocidal product for the EEA market if it complies with one of the following conditions:

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• It is approved for the specific product type in which it is used.

• It is included in the list of substances that do not give rise to concern for health and the environment (Annex I of the BPR)

• It is an existing active substance (already on the market on 14 May 2000) and is in the Review Programme

• From 01 September 2015, no biocidal products can be made available on the market unless either the active substance supplier or the product supplier is included on the Article 95 list of active substances and suppliers. Non-EU companies can be represented by an EU Representative, for the purpose of Article 95, and can be indicated on the list next to their EU Representative. Please contact us for details of how Arrow Regulatory can assist with this aspect of active substance compliance.

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Biocidal Products

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After the biocidal active substance has been approved, or included on the list of substances which do not give rise to concern (Annex I of the BPR), a biocidal product containing it must be authorised before it can be made available on the European Economic Area (EEA) market:

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• The authorisation holder is responsible for the placing of the product on the market (its first supply for distribution or use in the EEA). This includes responsibility for the correct classification (according to the CLP Regulation) together with packaging and labelling of the product.

• The authorisation holder is also obliged to inform the competent authorities of information that may affect the product authorisation, for example information about safety.

• The authorisation holder must be a natural or legal person established in the EEA and can be the manufacturer, importer or a consultant. Please contact us for discussion of Arrow Regulatory's proficiency when acting as authorisation holder.

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