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:
- Product’s data – technical leaflet, marketing authorization holder, producers of active ingredients.
- Identity of product – formula.
- Physical and chemical properties – product specifications, MSDS, specification for all raw materials and AS.
- Analytical methods for detection and identification – analytical methods for the determination of active substance.
- Efficacy studies – screening, laboratory and field tests.
- Toxicological and metabolic studies – acute toxicity, oral-dermal-inhalation, skin and eye irritation, skin sensitization, summary of mammalian toxicology and conclusions, including no observed adverse effect level (NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning the active substances.
- Ecotoxicological studies
- Measures necessary to protect humans, animals and the environment, such as Poison Centre Information and any other relevant information such as recommended methods and precautions concerning handling, use, storage or transportation, possibility of reuse or recycling, possibility of neutralization of effects, etc.
- Classification and Labelling – hazard symbol(s), indications of danger, risk & safety phrases, etc.
Disinfectants should undergo Stability testing. CIPAC protocols specify Storage & Temperature conditions to stress the product and prove stability. QACS Antimicrobial Efficacy studies include Stability testing for Biocides according to the CIPAC methodology to ensure Disinfectant Efficacy for a period of two years.