CHEMICAL REGULATION COMPLIANCE

We offer technical support and assistance to organizations/companies that need to achieve compliance with national and EU-level registration requirements for chemical substances and products.

INFOTOX consultants have relevant expertise in supporting organizations meet their regulatory requirements for:

 

 

Biocidal Products Regulation (BPR) - EU Regulation nº 528/2012 

- Dossier data gap analysis
- IUCLID dossier preparation
- R4BP application submission and updates
- (Eco)toxicological reviews (including QSAR)
- Design of testing programs
- Exposure and risk assessments
- Reviewing and updating marketing/efficacy claims
- Liaison with competent authorities
- Safety Data Sheets production 
- Summary of Product Characteristics production (SPC editor)
- Article 95 inclusion

 

 
Cosmetic Products Regulation - EC Regulation n.º 1223/2009
- Product Information Files (PIFs) data gap analysis
- Guidance on setting up PIFs
- Production of the Cosmetic Product Safety Reports (CPSRs), by certified EUROTOX registered toxicologist
- Product electronic notifications and CPNP number listing
- Reviewing and updating marketing/efficacy claims and product label
- Cosmetic Product Data Information Sheet production
- Guidance on setting up a post-market surveillance program
- Responsible person services
 
 

REACH  (Registration, Evaluation and Authorization of Chemicals) - EC Regulation n.º 1907/2006
- Dossier data gap analysis
- Registration and pre-registration services
- IUCLID dossier preparation, submission and updates
- (Eco)toxicological reviews (including QSAR)
- Design of testing programs
- Exposure and risk assessments
- Liaison with competent authorities
- (Eco)toxicological support for SIEF negotiations
- Chemical Safety Reports (CSR)
- Safety Data Sheets production
- Only representative services
 
 
Classification Labeling and Packaging Regulation (CLP) - Regulation n.º 1272/2008
- Classification and Re-classification of substances and mixtures in accordance with the CLP Regulation
- (Eco)toxicology reviews and expert support in the classification of substances with limited data
- Design testing programs (non-animal testing focus)
- CLP notification dossier preparation, submission and updates
- Authoring and updating Safety Data Sheets (SDS) 
- Reviewing and updating product labels
 

 

INFOTOX also provides technical support for:

- Food and Feed Regulation (CE) nº 178/2002

- Detergent Regulation (CE) nº 648/2004

- Environmental Risk Assessment for drugs

- Registration/Notification of Medical devices

 

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