Regulatory Compliance

Regulatory compliance is an important aspect of masterbatch manufacturing that ensures that any additives and/or Pigments used in your plastic products comply with regulations and guidelines set by governing bodies. This includes regulations related to safety, quality, and potential environmental impact.

At Colourhouse Masterbatch Ltd, we are committed to providing regulatory support and ensuring compliance across our entire range of masterbatch products developed for the pharmaceutical, food, and toy sectors.

Our compliance team ensures that all products are manufactured according to strict guidelines to safeguard the health and safety of end users.

Compliance with regulatory requirements involves a comprehensive understanding of relevant regulations and standards, as well as rigorous testing and documentation of the additives and pigments used within the masterbatch formulation.

For example, the FDA sets regulations for the use of additives in plastic products that come into contact with food in the United States. Similarly, the European Chemicals Agency (ECHA) sets regulations for the use of chemicals in the European Union. Compliance with ECHA regulations requires manufacturers to conduct comprehensive risk assessments and provide documentation to demonstrate that the use of the chemical does not pose an unacceptable risk to human health or the environment. .

Compliance with these regulations may involve testing for toxicity, migration, and other properties of additives, as well as maintaining detailed records of the composition and source of the materials used. Failure to comply with regulatory requirements can lead to legal and financial consequences, as well as damage to the reputation of the manufacturer.

In summary, regulatory compliance is a crucial aspect of masterbatch manufacturing that ensures the safety, quality, and environmental impact of plastic products. Manufacturers must have a comprehensive understanding of relevant regulations and standards and implement rigorous testing and documentation processes to meet these requirements, When ordering masterbatch, please inform us of your application and formulation's regulatory requirements, so that we can review these requirements to ensure compliance.

here are several links to some of the relevant policies:

1. ISO 9001:2015 Quality Management System - https://www.iso.org/standard/62085.html
2. ISO 14001:2015 Environmental Management System - https://www.iso.org/standard/60857.html
3. REACH Compliance - https://echa.europa.eu/regulations/reach/understanding-reach
4. SVHC List - https://echa.europa.eu/candidate-list-table
5. RoHS - https://www.rohsdirective.com/
6. Directive 2004/12/EC - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32004L0012
7. Regulation (EC) No 1935/2004 - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20190625
8. EMA/410/01 - https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-manufacturing-practice-medicinal-products-human-use_en.pdf
9. Regulation (EU) No 10/2011 - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011R0010
10. AP (89)1 - https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/90
11. BfR IX - https://www.bfr.bund.de/cm/343/guideline-for-the-assessment-of-articles-in-contact-with-food_en.pdf
12. FDA 21 CFR 177:1520 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=177.1520
13. FDA 21 CFR 178:3297 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=178.3297
14. EN71 Part 3:2013+A1:2014 - https://www.en-standard.eu/bs-en-71-3-safety-of-toys-part-3-migration-of-certain-elements/