In the Biocides Regulation, depending on the procedure followed for the registration of the product, several types of Letter of Access (LoA) exist and may be necessary.
The LoA for Section 95 Approved Suppliers
In order to place a biocidal active substance on the market during the transitional period, the supplier must be registered on the list of approved suppliers under Article 95 of the Biocides Regulation. This inclusion in the list of approved suppliers is done by active substance: a significant amount of information is therefore required for this type of procedure.
In order to submit a dossier to finalise this inclusion, a letter of access referring to an active substance dossier may be necessary. The purpose of this letter of access is to promote information sharing and to limit testing on vertebrate animals.
There are two major differences between Article 95 LoAs and other biocidal LoAs:
it should also be noted that the Article 95 LoA is not mandatory: companies can choose to re-register the active substance, although the costs are much higher in this case. Furthermore, the company supplying the LoA is obliged to charge for it, which is not always the case with biocidal LoAs.
LoAs regarding biocidal product MAs
Once an active substance is approved, in order to place a biocidal product on the market, it is necessary to submit an application for a Marketing Authorisation (MA), for which it is necessary tp provide data on the substance and on the biocidal product. In order to avoid costs related to the testing of active substances and also to limit tests on vertebrates (there is an obligation in Europe to share in vivo tests), it is possible for companies to purchase a letter of access on the active substance either from their supplier or from a consortium if necessary.
In addition, a second type of LoA may be required for the specific marketing authorisation procedure for the same product. In this case, since the dossier refers to a substance and product type already registered, a LoA is required for the biocidal product, as before. However, depending on the Member States, a LoA referring to the active substance may be requested in addition.
Finally, the main difference with an LoA acquired for an MA is that it can be provided free of charge by the supplier, if they wish.
REACH letters of access: more regulated than biocides
The REACH Regulation requires the registration of all substances produced or imported in excess of one tonne per year in Europe. The basic principle of registration is: one substance = one registration. For this purpose SIEFs (Substance information exchange forum) have been set up in which co-registrants submit together the joint part of the registration dossier containing general information on the substance, tests and other reports, plus the individual part of the registration dossier, specific to each company and the use of the substance.
To join an existing SIEF as a member registrant, a company must purchase a letter of access from the lead registrant. Letters of access for REACH registrations are more restricted than for biocidal LoAs, but the operation is similar. Costs are shared testing is limited, and the registrant saves time.
It is therefore essential to clearly differentiate between the LoA and these two regulations to avoid any confusion regarding the compliance and marketing of your products, mixtures or substances. If an active substance is manufactured or imported without any claim of foreseen use in biocidal products, then the requirements of registration under REACH apply. If, on the contrary, the active substance is imported only for a biocidal product, the BPR requirements apply. This also includes the appropriate requirements for classification, labelling and packaging of the biocidal product under Article 69 of BPR.
In the Biocides Regulation, depending on the procedure followed for the registration of the product, several types of Letter of Access (LoA) exist and may be necessary.
The LoA for Section 95 Approved Suppliers
In order to place a biocidal active substance on the market during the transitional period, the supplier must be registered on the list of approved suppliers under Article 95 of the Biocides Regulation. This inclusion in the list of approved suppliers is done by active substance: a significant amount of information is therefore required for this type of procedure.
In order to submit a dossier to finalise this inclusion, a letter of access referring to an active substance dossier may be necessary. The purpose of this letter of access is to promote information sharing and to limit testing on vertebrate animals.
There are two major differences between Article 95 LoAs and other biocidal LoAs:
it should also be noted that the Article 95 LoA is not mandatory: companies can choose to re-register the active substance, although the costs are much higher in this case. Furthermore, the company supplying the LoA is obliged to charge for it, which is not always the case with biocidal LoAs.
LoAs regarding biocidal product MAs
Once an active substance is approved, in order to place a biocidal product on the market, it is necessary to submit an application for a Marketing Authorisation (MA), for which it is necessary tp provide data on the substance and on the biocidal product. In order to avoid costs related to the testing of active substances and also to limit tests on vertebrates (there is an obligation in Europe to share in vivo tests), it is possible for companies to purchase a letter of access on the active substance either from their supplier or from a consortium if necessary.
In addition, a second type of LoA may be required for the specific marketing authorisation procedure for the same product. In this case, since the dossier refers to a substance and product type already registered, a LoA is required for the biocidal product, as before. However, depending on the Member States, a LoA referring to the active substance may be requested in addition.
Finally, the main difference with an LoA acquired for an MA is that it can be provided free of charge by the supplier, if they wish.
REACH letters of access: more regulated than biocides
The REACH Regulation requires the registration of all substances produced or imported in excess of one tonne per year in Europe. The basic principle of registration is: one substance = one registration. For this purpose SIEFs (Substance information exchange forum) have been set up in which co-registrants submit together the joint part of the registration dossier containing general information on the substance, tests and other reports, plus the individual part of the registration dossier, specific to each company and the use of the substance.
To join an existing SIEF as a member registrant, a company must purchase a letter of access from the lead registrant. Letters of access for REACH registrations are more restricted than for biocidal LoAs, but the operation is similar. Costs are shared testing is limited, and the registrant saves time.
It is therefore essential to clearly differentiate between the LoA and these two regulations to avoid any confusion regarding the compliance and marketing of your products, mixtures or substances. If an active substance is manufactured or imported without any claim of foreseen use in biocidal products, then the requirements of registration under REACH apply. If, on the contrary, the active substance is imported only for a biocidal product, the BPR requirements apply. This also includes the appropriate requirements for classification, labelling and packaging of the biocidal product under Article 69 of BPR.
