Stress free guide to product compliance

2021-03-08
ProductIP
Expert

What are plasticisers (softeners)?

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Plasticisers are chemical additives for making plastics or rubbers softer and more flexible.
Plasticisers are also called softeners because of this, phthalates are a well known type of plasticisers.
Plasticisers are added to polymers for the manufacturing of plastics. Plasticisers are mostly used in PVC, but a significant amount of plasticisers is also used in polymers like acrylics, polypropylene or polypropene (PP), polyethylene or polythene (PE), polyethylene terephthalate (PET) and polyurethanes.

Potential exposure to plasticisers

If plastic or rubbers parts have prolonged or repeatedly contact with the skin then plasticisers can be absorbed through the skin. If plastic or rubber parts are in contact with food, plasticisers can be unintentionally ingested via consumed food. Plasticisers can leak out of plastic and rubber materials that leads to exposure in the near environment.
Plasticisers can be hazardous for human health and the environment and are subject to chemical legislation.

Types of plasticisers

  • Phthalates (or phthalate esters)
  • Chlorinated Paraffins (e.g. short-chained SCCP)
  • Benzoate plasticisers
  • Trimellitate Plasticisers (TMA)
  • Citrate Plasticisers
  • Phosphates
  • Alkyl Sulfonic Acid Esters
  • Aliphatic Dibasic Acid Esters
  • Polyol-Carboxylic Acid Esters
  • Polymeric Plasticisers
  • Epoxies
  • Other Aliphatic Esters of Dibasic Acids
  • Bio-based plasticisers

Chemical risks and legislation

(A non exhaustive overview). The use of certain phthalates is restricted under the REACH Regulation (Annex XVII) and certain phthalates are listed as Substances of Very High Concern (SVHC) under the same regulation. Plasticisers may also be restricted or banned in the so called union list for plastic Food Contact Materials. Chlorinated paraffin's (especially SCCP) are subject of the POP regulation and regularly a cause for product recalls. The Toys Safety Directive also restricts the use of certain plasticisers in plastics and rubbers, refer to standard EN 71-9.

For compliance it is essential to know the composition or blend of your materials. Which polymers are used and what are their chemical properties. Which chemicals are used during manufacturing and which additives have been applied to give the end product the required properties.

For the chemical risk assessment of materials this is essential information from your supply chain.

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