Food & Feed Toxicology
Comprehensive solutions for safety assessment and authorisation of food and feed additives by EFSA and the European Commission.
Toxicological Services for Food & Feed
Specialised expertise in food safety assessment and regulatory compliance
In the European Union, food and feed additives may only be marketed once evaluated by the European Food Safety Authority (EFSA) and authorised by the European Commission.
Our team of food toxicology experts can support your company in designing the best strategy for the authorisation of your products, accompanying you throughout the regulatory process and facilitating your access to the European market.
With extensive experience in preparing dossiers for evaluation by EFSA, we guarantee an efficient and scientifically sound approach that optimises resources and maximises the chances of success.
Toxicological Regulatory Services for Food
Complete solutions for regulatory compliance of food and feed additives
Data Audit
Comprehensive evaluation of available information, identification of deficiencies and development of strategies to meet requirements established by EFSA.
- Review of existing studies
- Identification of information gaps
- Regulatory compliance analysis
- Evaluation of alternatives (in silico methods, read-across)
Acceptable Daily Intake Calculation
Scientific determination of the ADI (Acceptable Daily Intake) based on toxicological studies and appropriate safety factors.
- Establishment of NOAEL/LOAEL
- Application of appropriate uncertainty factors
- Exposure calculations for different populations
- Risk characterisation
Data Generation
Design, supervision and management of toxicological studies needed to demonstrate the safety of your products.
- Study protocol development
- Laboratory selection and coordination
- Study monitoring
- Evaluation and interpretation of results
Dossier Preparation Process for EFSA
Preliminary Assessment
Analysis of the product, definition of its regulatory category and strategic planning of the authorisation process, including the most appropriate route and expected timelines.
Technical Dossier Preparation
Compilation of all required technical, scientific and administrative documentation according to EFSA's specific formats and guidelines, ensuring its completeness and compliance.
Submission and Follow-up
Management of the dossier submission, communication with authorities and response to possible requests for additional information during the evaluation process.
Post-Evaluation Support
Assistance during the final phase of the process, including interpretation of the scientific opinion, adaptation to possible conditions of use and planning of market entry.
Authorisation Renewal
Complete management of the renewal process for existing authorisations, including updating data and adapting to new regulatory requirements.
- Update of existing documentation
- Evaluation of new scientific data
- Early planning of the process
- Follow-up throughout the procedure
Authorisation Modification
Assistance for the modification of existing authorisations, such as changes in conditions of use, specifications or expansion of applications.
- Impact assessment of proposed changes
- Preparation of supporting documentation
- Communication with authorities
- Strategies to minimise approval times
Monitoring and Surveillance
Continuous monitoring of the regulatory environment, alerting to regulatory changes that may affect your authorised products.
- Monitoring of regulatory changes
- Analysis of new scientific opinions
- Proactive risk assessment
- Early adaptation strategies
Strategic Advisory
Specialised consultancy to define the optimal authorisation strategy, considering scientific, regulatory and commercial aspects.
- Analysis of regulatory options
- Cost-benefit assessment
- Strategies to reduce authorisation times
- Comparisons with similar cases
Representation before Authorities
Technical and scientific representation of your company before EFSA and other European regulatory authorities.
- Effective communication with evaluators
- Participation in hearings and consultations
- Defence of scientific positions
- Resolution of objections or queries
Timeline Planning
Development of detailed schedules for the entire authorisation process, helping to plan resources and anticipate needs.
- Realistic deadline estimation
- Identification of critical milestones
- Contingency planning
- Coordination with commercial strategies
European Regulatory Framework
Areas of application and specific regulations for different product categories
| Regulatory Framework | Applications |
|---|---|
|
Food ingredients
Regulation EC 1331/2008 (CAP)
Regulation (EC) No 1333/2008 (food additives)
|
|
|
Feed additives
Regulation EC 1831/2003
|
|
|
Food contact materials
Regulation 1935/2006 (FCM)
Regulation 2023/2006 (GMP)
|
|
|
Nutrition
Regulation EC 1924/2006 (claims)
Regulation (EU) 2015/2283 (novel foods)
Directive 2006/141/EC (infant formula)
Directive 2003/89/EC (allergens)
Directive 2002/46/EC (food supplements)
|
|
|
Processing aids
|
Applications:
- Food additives
- Food enzymes
- Food flavourings
- Smoke flavourings
Applications:
- Technological additives
- Sensory additives
- Nutritional additives
- Zootechnical additives
- Coccidiostats and histomonostats
Applications:
- Plastic materials
- Recycled plastics
- Active or intelligent materials and articles
- Ceramics
- Regenerated cellulose film
Applications:
- Health claims
- Novel foods
- Traditional foods
- Infant formula
- Food allergens
- Nutritive sources