WTC has over 35 years of experience in the regulatory field of Food Contact Materials (FCM) and has extensive knowledge of the regulations applying to plastics, recycled materials, paper and board, coatings, multi-layer materials, rubber, elastomers, silicones, and printing inks, etc. in major countries of the European Union, Switzerland, the USA, Canada, China, Japan, etc.
Our expertise extends to national differences in regulatory requirements, ensuring compliance on plastics formulations with all local regulations. WTC has issued over 1700 compliance certificates and submitted over 500 successful petitions for food contact substances (monomers and additives) to the EFSA and national authorities, to the US-FDA, etc.
At WTC, we are committed to providing the best possible solutions for our clients and consumers worldwide. Contact us today to learn more about how we can help you meet your needs.
Regulatory Affairs Services - Streamline Your Compliance Process
Our team provides comprehensive regulatory affairs services to help you navigate the complex regulatory landscape. Our services include:
- Development of registration strategy and testing approach
- Compilation and submission of registration dossiers to regulatory authorities (EFSA, FDA, etc.)
- Safety assessment of non-intentionally added substances (NIAS)
- Expert reports and negotiations with regulatory authorities
- Compliance assessments and certification of food packaging materials
- Preparation of compliance documentation (according to Regulation (EC) No. 1935/2004)
- Consulting on Good Manufacturing Practice (GMP)
- Coordination and management of compliance testing
- Migration calculation / modelling
Our goal is to simplify the compliance process for our clients and ensure that their products meet all regulatory requirements. Contact us today to learn more about our regulatory affairs services.
Safety Testing Services - Ensure Product Safety
At WTC, we offer a full range of safety testing services to support your product development and ensure compliance with international regulations and standards. Our services include:
- Conception, monitoring, and management of experimental studies
- Physical-chemical property testing
- Migration studies
- Development/validation of analytical methods
- Mutagenicity and toxicity studies
- ADME studies
All tests are performed at a testing facility of your choice, following relevant international test guidelines such as OECD, ISO, EC, FDA, etc. Our team of experts provides project management and scientific monitoring to ensure the accuracy and integrity of your results. Contact us today to learn more about our safety testing services.
