Understanding of scientific techniques and practical context to dossier development.
Regulatory compliance is vitally important in today’s chemical industry. The business viability of chemical products now depends on conformity with health and safety and environmental legislation.
PFA‐Brussels can provide you with full support in fulfilling all the requirements of chemical regulations, such as Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH), Biocidal Products (BPR), and cosmetics.
REACH gives more responsibility to the chemical industry in risk management and safety information. It requires manufacturers and importers to gather information on the properties of their chemical substances and to register the information in a central database run by the European Chemicals Agency (ECHA).
Following successful registration, the regulatory submission must be kept up‐to‐date with new information, including any changes to chemical safety assessment. A registrant must be prepared to maintain the information in their dossier and also to react to information requests from ECHA. Furthermore, if the marketed tonnage increases to the next tonnage band, additional information is required.
With extensive experience in the field of environmental risk assessment, PFA‐Brussels offers services relating to compliance with legislation on biocides and cosmetics.
Biocidal Products Regulation
Biocidal products are categorised into 23 different product types such as wood preservatives, disinfectants or slimicides. EU law (Biocides Regulation 528/2012) requires that both active ingredients of biocides and the formulated biocidal products placed on the market must be authorised for all of the products’ applications.
Authorisation application involves the production of technical dossiers containing information on the properties of the active substance and each formulated product, and risk assessment for all uses. Important changes from the repealed Biocidal Products Directive (98/8/EC) include obligatory data sharing to reduce the need for new testing, and the introduction of mandatory deadlines.
11 July 2013 saw the full implementation of the new EU Cosmetics Regulation (EC) No. 1223/2009), which replaces the Cosmetics Directive (76/768/EEC). The Regulation specifically allowed the old cosmetics directive to be used up to this date.
The main target of the regulation is human safety. The regulation requires cosmetics to cause no damage to human health when applied under normal or reasonably foreseeable conditions of use. Environmental safety of cosmetics products is covered by REACH.
The most significant changes introduced include:
Strengthened safety requirements for cosmetic products
Specific requirements in the preparation of a cosmetic product safety report (CPSR), conducted prior to placing a product on the market, are specified.
Introduction of the notion of ‘responsible person’
A responsible person must be assigned for each cosmetic product and they must ensure that the cosmetic product is compliant with EU law.
Centralised notification of all cosmetic products placed on the EU market
The Cosmetic Product Notification Portal (CPNP) is the online European Commission central notification system. The information on the CPNP is available electronically to relevant bodies established by Member States.
Introduction of reporting of serious undesirable effects
The responsible person will have an obligation to notify serious undesirable effects to the competent authorities.
New rules for the use of nanomaterials in cosmetic products are in place
The new regulation should make enforcement easier, increase the knowledge base and communication, and put greater confidence in cosmetics products available on the market.
PFA knows how to apply best scientific knowledge to dossier development, which is essential for both regulatory acceptance and cost savings. Our understanding of scientific techniques and practical context enables us to make the best use of existing information, and to ensure that testing programmes are appropriate to the substance being registered.
We have expert knowledge of chemistry, degradation in the environment, toxicology and ecotoxicology, and thus can process dossier information correctly and with confidence.