Biocides supplier or user

If you supply or use biocidal active substances or products in the EEA, you need to be aware of the EU's biocides legislation. It is designed to make sure that the potential risk of harm caused by biocides are in balance with their expected benefits.

The law applies to 22 different product types, belonging to four main groups:

  • Disinfectants for home and industrial use
  • Preservatives for manufactured and natural products
  • Pest control products
  • Other specialist biocidal products, for example, antifouling products

It also covers substances, mixtures and articles which have been treated with, or intentionally incorporate, one or more biocidal products.

What do you have to do?

It depends on what you manufacture, supply or use – an active substance, a biocidal product or a treated article.

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

  • 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 (e.g. sold) or used

Exception: If the active substance is not yet approved but is in the Review Programme, the biocidal product can be made available on the market and used, subject to national laws.

In addition, as of 1 September 2015, all biocidal products may only be made available on the market if either the substance or product supplier is included on the Article 95 list of active substances and suppliers.

 

Active substances

All biocidal substances are covered. These include nanomaterials and active substances generated in situ (from another substance called a "precursor"), at the place of use.

Manufacturer or importer

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

  • 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

In addition, as of 1 September 2015, all biocidal products may only be made available on the market if either the substance or product supplier is included on the Article 95 list of active substances and suppliers.

To apply for approval of an active substance or inclusion in the Article 95 list, contact ECHA through the Register for Biocidal Products (R4BP 3).

Distributor

Before you start supplying an active substance for use on the EEA market, it must comply with the conditions described for manufacturers or importers above.

 

Biocidal products

Once the biocidal active substance has been approved, or included on the list of substances which do not give rise to concern (Annex I to the BPR), a biocidal product containing it must be authorised before you can make it available on the EEA market.

If a decision on the approval of the active substance has not been taken, you can still make the biocidal product available on the market, subject to national laws, as long as it is included in the Review Programme.

For all biocidal products, as from 1 September 2015, there must be a supplier (substance or product supplier) listed in the Article 95 list, otherwise the biocidal product can no longer be made available on the EEA market.

Authorisation holder

You are responsible for the placing of the product on the market (i.e. its first supply for distribution or use in the EEA). This means responsibility for the correct classification (according to the CLP Regulation), as well as the packaging and labelling of the product. You are also obliged to inform the competent authorities if at any time you become aware of information that may affect the product authorisation, for example information about safety.

It is your responsibility to make sure that the product conforms with the legal requirements when you advertise it or make it available on the EEA market. This applies to any form of supply, including distance selling and e-commerce.

If you are a prospective authorisation holder you can choose whether to apply for authorisation country-by-country or to go for an EU-wide authorisation.

Any natural or legal person established in the EEA can take on this role: including the manufacturer, importer or a consultant.

To encourage the use of biocidal products that are less harmful for health and the environment:

  • There is a simplified procedure for biocidal products using lower risk active substances
  • It is more difficult to obtain a product authorisation if an active substance contained in the product is identified as a candidate for substitution.

Manufacturer

As a manufacturer of a biocidal product you can apply to be the authorisation holder (see above).

You can also apply to be included on the Article 95 list as a "product supplier".

Importer

Before importing any biocidal product to the EEA, you should make sure that:

  • It has been authorised for marketing in the country where you intend to supply it or that the active substance in the product is in the Review Programme
  • A supplier is included on the Article 95 list of approved active substances and suppliers

As the importer of the biocidal product you can also apply to be on this list as a "substance supplier" or "product supplier". You can also apply to be the authorisation holder (see above).

Distributor

Before you distribute biocidal products, you should check that they are authorised for each of the countries in which you intend to make them available. 

If the biocidal product is not yet authorised, check that the active substance in the product is in the Review Programme.

Before distributing the product, as of 1 September 2015, you must also check that there is a supplier included on the Article 95 list of active substances and suppliers.

 

Treated articles

If your product has been treated with, or incorporates, a biocidal product but does not have a primary biocidal function, it is a "treated article".

A treated article can only be placed on the market (i.e. first supply for distribution or use in the EEA) if the biocidal product used for treating the article contains only:

  • Approved active substances
  • Substances that do not give rise to concern listed in Annex I
  • Substances included in the Review Programme
  • Specific labelling of the treated article may be required

Manufacturer or importer

If you are responsible for placing the treated article on the market, you take full responsibility for the legality of the treated article and for its traceability. You may also have to provide additional information for consumers, upon their request, about which biocidal products and nanomaterials have been used to treat the article.

Distributor

As a distributor of treated articles, you have the same responsibilities as a distributor of biocidal products.

You also have to provide information to consumers on which biocidal products and nanomaterials have been used to treat the article, when this is requested. It is the legal right of consumers to receive this information within 45 days and free of charge.

 

Exporting to non-EU countries?

If you are only exporting an active substance, a biocidal product, or a treated article, you are not bound by the rules of the Biocides legislation. 

However, if you are planning to export outside the EU a biocide that is banned or severely restricted within the EU, you will most likely have to comply with the requirements of the PIC Regulation. This means that you have to notify your Member State Designated National Authority (DNA) for PIC in advance to the export and provide the information required to accompany the exported chemicals. In addition, in some cases, consent from the importing country is required before the export can take place. If the export takes place, you will also have to report it to your DNA in the first quarter of the following calendar year.

Check whether your chemical is subject to PIC in the section on ‘Chemicals subject to PIC’.

Furthermore, you must package and label the exported chemicals – including all exported biocides irrespective of whether they are banned or severely restricted within the EU – according to the CLP Regulation. You must indicate the expiry date and the production date on the label, and if necessary give such expiry dates for different climate zones. You must also attach a safety data sheet to the shipment of the biocide when exported, and the information both on the label and on the safety data sheet shall as far as practicable be given in the official languages, or in one or more of the principal languages, of the country of destination or of the area of intended use.

 

Importing banned or severely restricted biocides into the European Union?

These could be active substances, biocidal products or articles containing banned or severely restricted biocides. In this case, you may need to comply with the requirements of the PIC Regulation.

If so, you need to:

  • Make sure that the import is allowed according to the BPR and your national legislation
  • Report on the imported quantities to the relevant authority in the EU

Check whether your chemical is covered in the section on chemicals subject to PIC.

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