New on data protection: Article 60 of the BPR
As a reminder, according to Article 60 of the BPR, the period of protection of data submitted for the approval of an existing active substance ends ten years after the first day of the month following the date of adoption of a decision, in accordance with Article 9, on the approval of the active substance concerned for the particular product type.
The data protection period submitted for the approval of a new active substance shall end 15 years after the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the active substance concerned for the particular product type.
The period of protection of new data submitted for renewal or review of the approval of an active substance shall end five years after the first day of the month following the date of adoption of a decision in accordance with Article 14(4) concerning the renewal or review.
However, Article 95(5) provides by way of derogation for data protection until December 31, 2025 for data submitted for SA/TP combinations for which no approval decision has been made before September 1, 2013.
It should be noted that data protection will end on December 31, 2025 for data submitted for SA/TP pairs included in the European Commission's review program. The December 31, 20265 deadline will apply while almost half of the SA/TP pairs in the review program are still being evaluated.
New data currently submitted due to new guidelines (e.g., efficacy guidance updated in 2022) or new requirements (e.g., endocrine disruptors).
As a result, applicants will be able to refer to this then unprotected data when submitting biocidal authorisation dossiers to the competent evaluation authorities and ECHA.
Referring to the data does not imply submitting a hard copy of the data in the application for authorization.
Changes to the SIMMBAD portal
The SIMMBAD (Système informatique de mise sur le marché des biocides : autorisations et déclarations) portal will soon undergo a complete overhaul and become BioCID (Catalogue, Inventory and Declaration of Biocidal Products). This redesign will include changes to simplify the declaration of products ("multiple creations", duplication of existing declarations) and the modification of existing declarations. It should be noted that from now on the declaration of new products to the inventory and quantities placed on the market will be centralized under the same account. The end of the recast is planned for the end of 2022.
Annual review of the dossiers examined by ANSES
ANSES (Agence Nationale de la Sécurité Sanitaire de l’alimentation, de l’environnement et du travail) has reviewed the dossiers submitted for active substances (AS) and biocidal products (BP). The agency expects a significant peak in submissions with the approval of DDAC and BKC in November 2022 (TP03 and TP04). A final approval date for DDAC TP01 and TP02 has been announced for February 2024. ANSES reminded us that the application procedures for evaluation must be done at least one year in advance. Concerning the AMM of The Union, it was evoked that the ANSES could take position only once the date of approval of the Active Substance (AS) is fixed.
Assessment of the controls on biocidal products in 2021: ECHA's labelling, claim and control plans
Out of 346 samples and 2250 references of biocidal products controlled in 2021, more than half of the products are considered non-compliant. In particular, it was found that the labels were not compliant (lack of information or readability problems). This is why the DGCCRF (Direction générale de la Concurrence, de la Consommation et de la Répression des Fraudes) has shared advice on labeling and authorized claims.
Integration of new regulatory requirements in the evaluation of a marketing authorization application
Significant delays have been noted with the eCAs (Evaluating Competent Authorities), often resulting in requests for additional information, particularly on new requirements. The delays are due to resource problems and the rapidly changing regulatory framework. Thus, further delays accumulate in the evaluation of the file.
In addition, following new regulatory requirements, some eCAs ask for additional data that are very constraining (heavy costs or short deadlines for the submission of new data).
New on data protection: Article 60 of the BPR
As a reminder, according to Article 60 of the BPR, the period of protection of data submitted for the approval of an existing active substance ends ten years after the first day of the month following the date of adoption of a decision, in accordance with Article 9, on the approval of the active substance concerned for the particular product type.
The data protection period submitted for the approval of a new active substance shall end 15 years after the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the active substance concerned for the particular product type.
The period of protection of new data submitted for renewal or review of the approval of an active substance shall end five years after the first day of the month following the date of adoption of a decision in accordance with Article 14(4) concerning the renewal or review.
However, Article 95(5) provides by way of derogation for data protection until December 31, 2025 for data submitted for SA/TP combinations for which no approval decision has been made before September 1, 2013.
It should be noted that data protection will end on December 31, 2025 for data submitted for SA/TP pairs included in the European Commission's review program. The December 31, 20265 deadline will apply while almost half of the SA/TP pairs in the review program are still being evaluated.
New data currently submitted due to new guidelines (e.g., efficacy guidance updated in 2022) or new requirements (e.g., endocrine disruptors).
As a result, applicants will be able to refer to this then unprotected data when submitting biocidal authorisation dossiers to the competent evaluation authorities and ECHA.
Referring to the data does not imply submitting a hard copy of the data in the application for authorization.
Changes to the SIMMBAD portal
The SIMMBAD (Système informatique de mise sur le marché des biocides : autorisations et déclarations) portal will soon undergo a complete overhaul and become BioCID (Catalogue, Inventory and Declaration of Biocidal Products). This redesign will include changes to simplify the declaration of products ("multiple creations", duplication of existing declarations) and the modification of existing declarations. It should be noted that from now on the declaration of new products to the inventory and quantities placed on the market will be centralized under the same account. The end of the recast is planned for the end of 2022.
Annual review of the dossiers examined by ANSES
ANSES (Agence Nationale de la Sécurité Sanitaire de l’alimentation, de l’environnement et du travail) has reviewed the dossiers submitted for active substances (AS) and biocidal products (BP). The agency expects a significant peak in submissions with the approval of DDAC and BKC in November 2022 (TP03 and TP04). A final approval date for DDAC TP01 and TP02 has been announced for February 2024. ANSES reminded us that the application procedures for evaluation must be done at least one year in advance. Concerning the AMM of The Union, it was evoked that the ANSES could take position only once the date of approval of the Active Substance (AS) is fixed.
Assessment of the controls on biocidal products in 2021: ECHA's labelling, claim and control plans
Out of 346 samples and 2250 references of biocidal products controlled in 2021, more than half of the products are considered non-compliant. In particular, it was found that the labels were not compliant (lack of information or readability problems). This is why the DGCCRF (Direction générale de la Concurrence, de la Consommation et de la Répression des Fraudes) has shared advice on labeling and authorized claims.
Integration of new regulatory requirements in the evaluation of a marketing authorization application
Significant delays have been noted with the eCAs (Evaluating Competent Authorities), often resulting in requests for additional information, particularly on new requirements. The delays are due to resource problems and the rapidly changing regulatory framework. Thus, further delays accumulate in the evaluation of the file.
In addition, following new regulatory requirements, some eCAs ask for additional data that are very constraining (heavy costs or short deadlines for the submission of new data).
