Placing on the market of biocidal products

What is a biocidal product?

According to the official definition, a biocidal product is:

• any substance or mixture, in the form in which it is supplied to the user, 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,
• any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used 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.

Source : Règlement (UE) N°528/2012

Biocidal products must therefore be effective whilst ensuring a high level of protection of both human and animal health and the environment. That is why biocides are strictly regulated according to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012. All biocidal products intended to be placed on the market must be authorised and the active substances contained in these products require prior approval.

Due to the current health emergency in our country (COVID-19), Efor is summarising the requirements for placing these products on the market.

What active substances can be used?

Any active substance (AS) must be authorised by Regulation (EU) No 528/2012 for the desired product type. Indeed, the Regulation introduces formal exclusion and substitution criteria. ASs must be approved by the European Commission. However, ASs that are under evaluation as part of the Review Programme for existing ASs, led by the European Commission, can also be used. The European Chemicals Agency (ECHA) website lists the ASs authorised by the European Commission, the products authorised in all European countries and the ASs included in the European Review Programme. The percentage of the AS in the formula must comply with the various national and/or global recommendations depending on the desired target.

The stability, viability and efficacy of the product must be assessed from a microbiological and toxicological point of view. The methodology used for the various tests must comply with the regulations (Regulation (EC) No 440/2008) and standards in force.

It is also possible to use a subcontractor that will supply a master formula. The supplier of the AS must be authorised, according to the list defined in Article 95 of the Regulation. This supplier shall then send a letter of access stating that the data may be used for the benefit of a third party (i.e. the biocidal product manufacturer) by competent authorities, the Agency, or the Commission for the purposes of Regulation (EU) No 528/2012. The supplier of the AS is required to share all toxicological and ecotoxicological studies performed on the substance. The ECHA website lists the suppliers authorised to sell the desired AS.

What procedure should be chosen when placing a biocidal product on the market?

Marketing authorisations (MAs) for biocidal products are issued at national or European level.

• National authorisation: if the product is being placed on the market in a single country, the company must submit its application for authorisation via the European Register for Biocidal Products (R4BP platform). The Member State Competent Authority (MSCA) will evaluate the application.
• Mutual recognition: if a company wants to extend the national authorisation of a product to other markets, it has to ask the other Member States to recognise the national authorisation. The application is also submitted via R4BP, specifying the MSCAs concerned.
• Union authorisation: an authorisation to place a biocidal product on the EU-wide market can be granted if the product has similar conditions of use throughout the Union except for products containing active substances meeting the exclusion criteria and those belonging to certain product types specified in the Regulation. The company must then submit the application via R4BP.
• Simplified authorisation: an application can be submitted for any biocidal product that does not contain a substance of concern or any nanomaterials; it must be sufficiently effective and its handling and use must not require personal protective equipment. The application must be submitted via R4BP, indicating which MSCA will assess the application. If a simplified authorisation is granted, the product can be placed on the market in other Member States without the need for mutual recognition.

What declarations are required for an MA in France?

In France, national authorisation (see above) is issued by ANSES in accordance with Decree No 2016-859 of 29 June 2016 on the procedures for approving and making available on the market and for declaring biocidal products and active substances.

Before a biocidal product can be placed on the French market, it must be declared to the French inventory (Simmbad declaration). This can be done electronically on the following website: https://simmbad.fr. The declaration must include various pieces of information, listed in Annex 3, in accordance with Decree No 2014-1175 of 13 October 2014. Every year, the quantities of biocidal products sold during year N-1 must also be declared.

For toxicovigilance purposes, each biocidal product must be declared to INRS and Poison Control Centres (CAPs), before it can be placed on the market. In accordance with Decree No 2014-128 of 14 February and the Ministerial Order of 25 January 2017, this declaration must be submitted electronically on the following website: https://www.declaration-synapse.fr/.

Hand sanitiser gels and solutions: what measures has the government put in place to facilitate their marketing during the COVID-19 pandemic?

Article 55(1) of Regulation (EU) No 528/2012 allows competent authorities to authorise the placing on the market of a biocidal product if they consider that such a measure is necessary because of a danger to public health.

Therefore, following the spread of COVID-19 and in order to reduce the transmission of the virus, hand sanitiser gels and solutions benefit from a derogation until 31 May 2020 for their placing on the French market. Indeed, companies can temporarily market their products if they comply with the Ministerial Order of 13 March 2020 amended by the Ministerial Order of 20 March 2020. After 31 May 2020, hand sanitiser gels and solutions will have to comply with Regulation (EU) No 528/2012 if they are to continue to be placed on the market.

What if all this information is confusing to me?

Our Efor regulatory affairs experts will be pleased to offer you high-quality support with regard to all of the following topics:

• From the formulation phase, by checking the regulatory compliance of the formula. We can also propose other alternative ASs.
• By carrying out scientific monitoring, to check the compatibility of the product with the target.
• By checking that the desired claims can be used for a biocidal product according to Regulation (EU) No 528/2012 and Regulation (EU) No 1272/2008. Our experts can also assist you in determining the types of tests to be implemented to justify the desired claims (efficacy, toxicity).
• For the validation of texts and artwork compliant with Regulation (EU) No 528/2012 and Regulation (EU) No 1272/2008.
• For the various declarations to be made.

Contact our teams using the contact form