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BIOCIDES
The regulation (UE) nº 528/2012, Regulation on biocides, regulates their commercialization and use. All biocides require an authorization to be able to market them and the active substances they contain must be previously approved.
Types of biocides:
main group 1: DISINFECTANTS (TP1-TP5)
main group 2: PRESERVATIVES (TP6-TP13)
main group 3: PESTICIDES (TP14-TP20)
main group 4: OTHER BIOCIDES (TP20-TP22)
Depending on the group you belong to, the competent agent that regulates it is different. Thus:
REGISTRATION OF BIOCIDES BEFORE AEMPS
Thus, there are a series of biocides what, for its purpose, are the competence of the Spanish Drugs and Medical Devices Agency. Within these we find:
- kind of product 1. Biocides for human hygiene Antiseptics for healthy skin.
- kind of product 2. Disinfectants used in public health settings: sanitary disinfectants.
- kind of product 19. Repellents for human hygiene.
Any biocide included in one of the above categories must be registered in the application provided by the AEMPS. From Burotec, we can help you both in the classification of your product and in the process and documentation necessary for its registration.
REGISTRATION OF BIOCIDES BEFORE THE MINISTRY OF INDUSTRY
The rest of the biocides not included in the previous sections are the responsibility of the Ministry of Industry, that must register in the portal enabled for it, the product must have the necessary technical documentation.
Our experts in this field will be able to accompany you throughout the registration process, as well as in the preparation of the documentation that your product needs to be in accordance with current legislation.
- PREPARATION OF PRODUCT INFORMATION FILE
- REDACTION OF SAFETY DATA SHEETS
- LABELING REVIEW
- MINIMUM QUALITY REQUIREMENTS