Chemical Product Safety – European Union

Records:

• Individual registration and identification of substances.
• Complete registration.
• Analysis of isolated intermediates.

Authorizations:

• Identification of uses of SVHC substances.
• Analysis and identification of SVHC substances contained in articles.
• Notification of SVHC substances in articles.

Registration and Evaluation:

• Development of complete registration files (Lead Registrant) and individual (SIEF / Consortium members), as well as intermediates.
• Preparation of the application for authorization of biocides and framework formulations or biocidal products and applications through the simplified procedure.
• Development of approval applications, modification of the approval conditions and renewal of the approval of biocidal active substances.
• Union authorization requests and authorization renewal.
• Requests for alternative supplier of biocides.
• Development of the technical equivalence dossier.

Biocides Regulation:

• Applications for national authorisation and authorisation renewal as well as mutual recognition and modification of approval conditions.
• Preparation of the Preliminary Risk Assessment and Exposure Scenarios.
• Preparation of applications for authorisation of biocides and framework formulations or biocidal products and applications under the simplified procedure.
• Preparation of applications for approval, modifications in the conditions of approval and the renewal of the approval of biocidal active substances.
• Applications for union authorisation and authorisation renewal.
• Applications for alternative biocide supplier.
• Preparation of Technical Equivalence Dossier.

Management of consortia, forums and laboratories:

• Administrative, technical and economic management of SIEFs and consortia.
• Representation in information exchange forums and consortia.
• Laboratory management, monitoring and subcontracting of characterization and identification tests, physicochemical and (eco) toxicological studies, as well as the efficacy of biocides, etc.
• Legal advice through a law firm specialized in the regulation of chemical substances.

Classification and labeling:

• Classification of substances and mixtures: CLP Regulation – GHS (GHS), R.D. 363/1995, R.D. 255/2003, ADR…
• Classification and labeling procedures for families of mixtures.
• Notification of classification of substances.
• Advice on changing the harmonized classification.
• Labeling of substances and mixtures.
• Label design.

Communication in the supply chain:

• Safety data sheets for substances and mixtures.
• Extended safety data sheets.
• Information sheets on substances and mixtures (Article 32).
• Analysis of use maps, exposure scenarios and safety reports on the use of substances by downstream users.
• Communications of use to the agency.
• Supplier safety data sheet audits.

Planning, implementation and regulatory and technical advice:

• Identification of obligations and planning of actions.
• Compliance audits and development of management systems and procedures.
• Analysis of intermediate substances.
• Assistance with inspections and safety audits.
• Advice to companies and business organizations.
• Helpdesk service.

Training:

• Tailored and personalized training. In-company training.
• Open training.