SGS Issues Guidance on Phthalates for Manufacturers Accessing EU Markets
SGS expert Dr. HingWo Tsang has written a helpful guide to the various regulations restricting phthalates in consumer products.
- (1888PressRelease) April 30, 2019 - SGS has published a helpful guide for manufacturers seeking to access European Union (EU) markets, who may fail because of non-conformity with regulations concerning phthalates.
Ortho-phthalates, commonly known as phthalates, are a ubiquitous family of synthetic chemicals that are found in a diverse range of products. They have, however, been linked to various health issues, including interference with endocrine (hormone) systems, male fertility matters, obesity and diabetes. The EU, as in other jurisdictions, has sought to regulate their use through various pieces of legislation.
The ubiquity of phthalates in consumer products stems from their usefulness and their relative cheapness. Primarily they are used as a plasticizer in polymeric and rubber materials. They can also be used as dispersion agents, enteric coatings, emulsifying agents, gelling agents, solubilizers (solvents), stabilizers or viscosity control agents.
They are found in:
• Adhesives and sealants
• Decals and printed designs
• Paints and similar surface coating materials
• Polyurethane (PU)
• Rubber materials
• Soft or flexible polymers or plastics
• Vinyl-based polymers such as polyvinyl acetate (PVA), polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC)
Part of the problem with phthalates is they are not chemically bound to their substrate materials, meaning they can be readily released by evaporation or migration, and so humans can be exposed to them through inhalation, skin-contact or ingestion.
The EU has several pieces of legislation that include restrictions on phthalates. These include:
• Regulation (EC) 1272/2008 – Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation)
• REACH – Regulation (EC) 1907/2006
• Directive 2008/98/EC ‘Waste’
• Directive 2009/48/EC ‘Toy Safety Directive (TSD)’
• Directive 2011/65/EU ‘RoHS Recast’
• Regulation (EU) 10/2011 ‘Food Contact Plastics’
In addition to these regulations, manufacturers also need to be aware of specific standards and pieces of legislation relating to individual Member States. For example, Denmark restricts all phthalates in toys and childcare articles for children up to three years old (Danish Statutory Order 855 of September 5, 2009).
SGS’s article, “Accessing the Market: European Union Phthalate Regulations”, provides a useful overview of some of the regulations that control the use of phthalates in the EU. It details a variety of commonly restricted phthalates and the products from which they are restricted.
To learn more: “Accessing the Market: European Union Phthalate Regulations”: [www.sgs.com/en/news/2019/04/accessing-the-market-european-union-phthalate-regulations]
SGS REACH Services
SGS keeps interested parties informed about developments and changes to REACH regulations. Their expertise, combined with consultancy services and experience in consumer product supply chains, provides a central point of contact for global solutions. Learn more about SGS’s REACH Services. [www.sgs.com/reach]
For more information, please contact:
HingWo Tsang
Global Information and Innovation Manager
Email: crs.media ( @ ) sgs dot com
Website: www.sgs.com/cgnr
About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
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