Regulatory Compliance services for Biocides
At QACS we provide a range of solutions for Biocides in order to prove Product Efficacy and Biocidal Regulatory Compliance. Before placing biocidal products on the market authorization must be obtained. A dossier for a Biocide Product is compiled and submitted for approval to the Competent Authorities of each Member State.
According to Article 45 and Annex VIII to the CLP Regulation, there are certain obligations for biocidal products (as chemical mixtures) that are classified as hazardous on the basis of their health or physical effects. These include a properly generated UFI code on the label and the relevant PCN submission covering each Member State’s market placement. QACS team ensures compliance of your product by generating the UFI code and submitting the PCN dossier on behalf of your company.
Since biocidal products fall under the REACH and CLP Regulations for chemical products they need to be accompanied by a compliant and up-to-date Safety Data Sheet (SDS). Classification, label requirements and the need for PCN submission, all depend on the information provided in the product’s SDS. QACS team of experts is dedicated to the classification study and the compilation of the SDS for your product.
Biocidal label compliance with the provisions of BPR, CLP and national Regulations is crucial prior to market placement. QACS team provides label marketability services and support in order to ensure regulatory compliance for your product’s label.
The authorization of a biocidal product is specific to the company responsible for placing the product on the market. The following documentation is necessary to register your products:
- Trade name of the product exactly as placed on the market.
- Details of the product’s manufacturer / packer and Declaration by both companies indicating their commercial relationship as far as the biocidal product is concerned, should be also provided.
- Composition of the product (% w/w or v/v) indicating both active and inactive substances with the relevant CAS numbers.
- Identity of the active substances, details of the initial manufacturer and all the intermediate suppliers along with the relevant MSDSs.
- Letter of Supply (LoS) of the initial manufacturer and all the intermediate suppliers of the active substances (all the above-mentioned companies must be present in the list of Article 95, Reg. 528/2012).
- MSDSs of the raw materials (both active and inactive), TDSs and CoA
- Physicochemical characteristics of the final product.
- MSDS of the final product in Greek.
- Identification and analysis of the biocidal product (especially the active substances) and method description.
- Efficacy tests (ΕΝ protocols) and suggested uses based on the tests’ results.
- Product type, field of application (e.g., general public or professional use), dosage and contact times, instructions of use, expiration date.
- Measures for the protection of humans, animals and the environment.
- Packaging details (material and capacity).
- Labels for all different containers (in Greek).
- Technical manual leaflet, if available (in Greek).
- Toxicological / Ecotoxicological data on the final product.
- For products produced in Greece: Production license issued by the Circulation Control Section of the National Organization for Medicines.
- Original deposit receipt of the required fees.