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Antifoulings used to protect boat hulls against marine fouling are now subject to particularly strict European regulations. Against this backdrop, Breton manufacturer Nautix has announced that it has obtained its Marketing Authorizations (MA) for its Yachting range, designed for pleasure craft, and its Formula+ range, reserved for professional use.
These authorizations, issued for ten years, enable products to continue to be sold and applied in France.
Authorization now essential for antifoulings
Since the entry into force of EU Regulation No. 528/2012 on biocidal products, known as BPR for Biocidal Products Regulation, antifoulings have been among the products strictly regulated at European level. In this classification, antifoulings belong to the TP21 category, which groups products designed to control the development of organisms and microorganisms on boat hulls or other submerged structures.
The regulations have a dual objective. They must facilitate the circulation of products within the European Union, while guaranteeing a high level of protection for human health, aquatic organisms and the marine environment. In practice, antifouling containing active substances can no longer be legally marketed or applied without a Marketing Authorization.
A long and closely supervised scientific evaluation
Obtaining marketing authorization is based on a particularly demanding assessment procedure. The authorities examine a number of criteria, including the product's efficacy, its impact on the environment and potential risks to humans. In France, this assessment is carried out by the Agence nationale de sécurité sanitaire, Anses, which has been delegated by the French government to authorize or prohibit the marketing of biocidal products.
Studies take into account various exposure scenarios, including skin penetration during application or diffusion of substances into the marine environment, and ecosystem impacts are analyzed using models covering different European port configurations and shipping areas. As with medicines, the final decision is based on an analysis of the benefit-risk ratio. Only products whose efficacy has been demonstrated and whose risks are deemed to be under control are granted authorization.
For Nautix, applications were submitted in 2018. After several years of scientific evaluation, the first decisions have just been published.
Regulatory safety for professionals and yachtsmen
The granting of these marketing authorizations means that Nautix products will remain available on the French market for the next ten years. This confirmation directly concerns several players in the marine industry. These include shipyards that carry out careening operations, shipchandlers who distribute antifouling products, and boat owners.
For professionals, the challenge is to be able to continue working with products that comply with current regulations. In the event of an administrative inspection, the use of an authorized antifouling avoids any legal challenge. For users, this validation is also a guarantee of product safety and effectiveness.
European regulations are still evolving
All manufacturers on the market must now comply with this authorization procedure. Eventually, only antifoulings with a valid AMM number will be allowed to be marketed and applied in Europe. Products failing to obtain this authorization will have to be withdrawn from the market.
For boaters and professionals alike, it's essential to check the information on the labels of the products they use.
The role of the nautical industry in the evolution of the regulatory framework
The Fédération des Industries Nautiques also played a role in this regulatory process. In particular, it took part in the socio-economic impact studies carried out upstream of the decisions. The organization highlighted the reality of the French fleet of boats afloat, and the activity of refit yards and specialized distribution networks. It also highlighted the benefits of antifoulings in reducing fuel consumption and controlling the spread of invasive species.
In particular, this consultation has enabled the non-professional application of certain antifoulings to be maintained, provided that users are accompanied by recommendations on the use of personal protective equipment during application. For professional use, Certibiocide training remains compulsory for distributors, purchasers and applicators of biocidal products.
A Breton manufacturer based in Morbihan
Nautix formulates and manufactures its marine paints in Guidel, Morbihan. The company employs around twenty people and exports around 40% of its production. For its teams, obtaining these MAs represents the culmination of several years' work in research and development to adapt formulations to European regulatory requirements.
In an increasingly regulated sector, this validation gives shipyards, distributors and yachtsmen the guarantee of being able to continue using these antifoulings legally for the next decade.
