Biocide notification: Germany, France and Norway compared

Before a biocidal product such as an insect repellent reaches a shelf in Germany, France or Norway, someone has to tell the national authority it exists. This article compares biocide notification in the three countries, for distributors and brand owners who place products on these markets.

What biocide notification means under the BPR

The EU Biocidal Products Regulation, (EU) No 528/2012, aims for every biocidal product to hold an authorisation. While an active substance is still under review for a product type, Article 89 lets member states keep their own national rules for products that contain it.

That is where notification comes in. A notification is not an authorisation. It tells the authority which product is on the market, who is responsible for it and what it contains, and it is a condition for selling it.

Once every active substance in a product is approved for its product type, the national route stays open only if an application for product authorisation was submitted by the approval date of the last substance. Without one, the product has to leave the market 180 days after that date, and existing stocks may be used for up to 365 days.

The regulation also requires, in every country, that the supplier of the active substance or of the product appears on the ECHA list kept under Article 95, for the right product type.

Biocide notification in Germany: BAuA and the N-number

In Germany the rules sit in the Biozidrechts-Durchführungsverordnung (ChemBiozidDV), in force since August 2021. A product that relies on the transitional rules must be notified to the Federal Institute for Occupational Safety and Health (BAuA) before it is first placed on the market, through the authority's electronic form.

The notification doubles as an application for a registration number. That number, an N followed by five or six digits, must appear on the product. Notified products and their numbers are listed in the public database eBIOMELD.

A notification is not a one-off. It has to be updated when the notified details change, and its accuracy has to be confirmed every two years.

France: the BioCID inventory and yearly quantities

In France, the Environment Code (articles L522-2 and L522-3) requires the company responsible for making a biocidal product available to declare it to ANSES, the national agency for food, environmental and occupational health, before it first reaches the market.

The declaration goes through BioCID, the online service that has replaced the earlier Simmbad portal. Non-confidential details, such as the trade name, the active substance and its concentration and the product type, are published.

France adds a second duty. Each year, the company declares the quantities of each product placed on the French market in the previous year.

Norway: Produktregisteret and a Norwegian label

Norway applies the BPR through the EEA Agreement, and the Norwegian Environment Agency (Miljødirektoratet) runs the national transitional rules. Under the Norwegian biocide regulation (biocidforskriften), every biocidal product must be reported to Produktregisteret, the Norwegian product register, whatever the quantity and whatever its classification.

Products sold under the transitional rules must be labelled in Norwegian and must not be marketed in a misleading way. Products that carry CLP labelling and are sold in quantities of 100 kg or more a year also have to be declared under a separate regulation.

A biocide notification checklist before the first delivery

Before a new product ships to any of the three countries, check these points.

• Which company places the product on each market, and therefore which company notifies.
• The Article 95 listing of the active substance supplier or the product supplier, for the right product type.
• Germany: the N-number from BAuA, printed on the product, and a date for the two-yearly confirmation.
• France: the BioCID declaration before the first sale, and the yearly quantity declaration in the calendar.
• Norway: the Produktregisteret report and a label in Norwegian.
• The approval date of the last active substance, which sets the deadline for an authorisation application.
• A label in the local language and the set advertising sentences of Article 72, in every market.

Rules change and each authority publishes its own guidance. Check the current text before every first delivery to a new market.

For Repeltec, Affix Labs Netherlands B.V. holds the files per market.

Distributors who want to add Repeltec to their range will find the terms on the Partners page on affixlabs.com. Trade customers can follow the status per market on the status page of the Pro portal on repeltec.com.