Patrokles QA Manager

Guidance on Phthalates for Manufacturers Accessing EU Markets

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. 

Patrokles QA Manager now includes a helpful guide for manufacturers and importers seeking to sell on European Union (EU) markets, who may fail because of non-conformity with regulations concerning phthalates. 

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 mostly 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 covering restrictions on phthalates, including:

  • REACH – Regulation (EC) No 1907/2006
  • ROHS – Directive 2011/65/EU
  • Toy Safety – Directive 2009/48/EC
  • Plastic Food Contact Materials (FCM) – Commission Regulation (EU) No 10/2011

In addition to these regulations, manufacturers also need to be aware of specific standards and pieces of legislation relating to individual Member States that may go above and beyond EU regulations.

Patrokles QA Manager – Quality Assurance Done Right

We have recognised that managing all aspects of product compliance, including control of harmful Phthalates, requires not just domain knowledge but also a dedicated software solution to streamline day to day activities that quickly spiral out of control if shared file storage, spreadsheets and email are the only tools at your disposal.

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Guidance on Phthalates for Manufacturers Accessing EU Markets
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