Assistance With Biocidal Product Applications

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved.

The approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition.

The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products. It also promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.

Scope: Articles 62, 63 and 95 of the BPR

An inquiry to share data is obligatory before performing any tests or studies involving vertebrates. This step determines whether such tests or studies have already been submitted under the Biocidal Products Directive (BPD) or the Biocidal Products Regulation (BPR).

The purpose of data sharing is to avoid unnecessary or repeat testing, in particular on vertebrate animals and to support resolutions on data sharing disputes (Article 63 of the BPR).

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A separate application is needed for each concerned Member State

An application for a mutual recognition in sequence can be submitted when a company has been granted a national authorisation for a biocidal product or product family, in one Member State (reference Member State) and wishes to make that product available on the market of another Member State (concerned Member State).

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The authorisation is based on the evaluation of a single product

An application for national authorisation under the clause same biocidal product to the Member State Competent Authority that authorised the reference product or is evaluating it, under either of these conditions: The biocidal product or product family is identical to a reference product or product family which has received a national authorisation ('authorised'), or for which an application for national authorisation has been submitted by an other party and the decision-process is still going on ('pending').

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One separate application must be submitted for each change sought

If an intended change is not listed in one of the tables in the Annex to the Changes Regulation (Regulation (EU) No 354/2013), the authorisation holder may request an opinion from ECHA on the classification of that change in accordance with the criteria laid down in the Annex to the Changes Regulation.

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In the absence of an opinion from the competent authority within 45 days of the notification, the notified experiment or test may take place

Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment must first notify the competent authority of the Member State where the experiment or test will occur.

The notification should include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health, or the impact on the environment. The person concerned must make any other information requested by the competent authorities available.

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A notification is required for each new product within the product family

If a Member State has authorised a biocidal product family, the authorisation holder can place a product within this product family on its market after having notified the competent authority at least 30 days in advance.

However, a notification is not needed if the product was explicitly identified in the authorisation, or if the variation in composition concerns only pigments, perfumes and dyes within the permitted variations.

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The union authorisation process is a voluntary process

The Biocidal Products Regulation (BPR) introduces the possibility to have certain biocidal products authorised at Union level. Provided that products have similar conditions of use across the Union, this allows companies to place their biocidal products on the market throughout the entire Union, without the need to obtain a specific national authorisation.

Products belonging to product types 14, 15, 17, 20 and 21 are excluded from the scope of Union authorisation, as well as products containing active substances meeting the exclusion criteria.

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The active substances used within the biocidal product must have previously been approved at the Union level

Biocidal products need to be authorised before they can be made available on the market or used within the Union.

Applications for a national authorisation are specific to the EU Member State where the product will be placed on the market.

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A separate application is needed for each concerned Member State

An application for mutual recognition in parallel can be submitted when a company is applying for a national authorisation for a biocidal product or product family, in one Member State (reference Member State) and wishes to make that product available on the market of another Member State (concerned Member State).

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No less than 30 days early notice required

Biocidal products and product families can be authorised in a simplified procedure under certain conditions.

A holder of a simplified authorisation can make the biocidal product available on the market in other EU Member States without mutual recognition but needs to notify the Member State in question at least 30 days before placing the product on its territory.

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When an introduced biocidal product is identical to an autorised product from the origin Member State

Following a successful application for a parallel trade permit, the holder of the permit is allowed to make available on the market a biocidal product in one Member State (Member State of introduction) if the biocidal product is authorised in another Member State (Member State of origin) and if the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (the reference product).

The competent authority of the 'Member State of introduction' will examine whether the two biocidal products are identical in accordance with the legislation and may request information from the 'Member State of origin' that granted the authorisation to the reference product. .

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The grouping of changes is also possible in certain circumstances

There are two types of administrative changes: those requiring prior notification before implementation and those which can be notified after implementation.

The Changes Regulation (Regulation (EU) No 354/2013) sets out the procedure to notify an administrative change for a product authorisation.

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The grouping of changes is possible in certain circumstances.

A minor change means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited reassessment of the properties or efficacy of the biocidal product or family of products.

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The grouping of changes is possible in certain circumstances.

A major change of a product is a change that can be expected to affect the conclusion with regard to the fulfilment of the conditions of Articles 19 or 25 of the Biocidal Products Regulation (BPR).

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The notification must be submitted without delay. Ref Art. 47 of BPR

Notification to the competent authority that granted the authorisation is required when an authorisation holder becomes aware of an information concerning an authorised biocidal product or the active substances in it, that could affect the validity of a such authorisation.

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A Member State can take steps to restrict or prohibit the product being made available in its territory

A biocidal product that was authorised in a simplified procedure in an EU Member State can be placed on the market in all other Member States without mutual recognition.

The authorisation holder must notify a Member State at least 30 days before placing the product on the market in its territory. The product must be labelled in the official languages of the Member State unless that Member State provides otherwise.

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Scope: Article 31 of BPR

An application for the renewal for the national authorisation of a biocidal product-type or product-types, need to be submitted to the competent authority at least 550 days before the expiry date of the authorisation or the earliest expiry date for a product-type.

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Entry point for all regulatory services related to: Biocides, Applications for New Active Substances