Factsheets

INFORMATION ABOUT PHTHALATE PLASTICISERS

• Plasticisers have been used to soften materials since ancient times: for example, water to soften clay and oil, mixed with pitch, to seal boats.
• Modern plasticisers use the same principle. Combined with PVC (or other polymers), they provide unique physical and technological properties, used in a myriad of applications in articles and products that are integral to our daily lives.
• Today, nearly 6 million tonnes of plasticisers are used every year throughout the world, including 1 million in Europe. Phthalates represent more than 80% of this volume.

Phthalates are plasticisers obtained from a reaction between phthalic acid and an alcohol and form a diverse family of chemical substances. They are split into two sub-groups which have different properties and effects.
• High molecular weight phthalates or “high phthalates”, such as DINP, DIDP and DPHP, constitute more than 80% of the phthalates used in Europe. These substances are registered under the European regulation on chemical substances (REACH) and are non-classified for any health and environmental hazard.
• Low molecular weight phthalates or “low phthalates”, such as DBP, BBP, DIBP and DEHP, are recognised as "substances of very high concern" (SVHC) by REACH because of their effects on reproduction in animal studies.

• Phthalates are mainly used in industrial applications as additives for polyvinyl chloride (PVC). They give PVC the flexibility and elasticity needed for many different applications, particularly in construction (sheathing for electric cables, roofing membranes, flooring and wall coverings), in the automobile industry (trim, cables, under body sealants), furniture and artificial leather goods.

• The European authorities have evaluated the most commonly used high phthalates (DINP, DIDP) extensively with the conclusion that no classification is required for any health or environmental hazard, and that additional risk control measures are not required. Based on the precautionary principle, it was only considered that high phthalates (DINP, DIDP) should not be used in toys and childcare items which could be put into the mouth.
• The risk assessments carried out by European authorities led to low phthalates being classified as Category 1B Reproductive Agents: For this reason, and based on the precautionary principle, they may not be used in toys and childcare items , nor in cosmetic applications . Their use is also regulated in food plastics packaging and processing applications. Under the REACH Regulation, low phthalates are subject to authorisation which means that after August 2015, they may only be manufactured and placed on the market if specific authorisation for that application and/or use in that supply chain has been granted.

• What about medical devices containing phthalates? European directives relative to medical items require strict, complete testing of all materials and oversee their use. Several medical devices contain the low phthalate DEHP which is included in the European Pharmacopoeia as a plasticiser for medical device use. The use of DEHP is important in medical packaging and medical devices (including blood bags) and immediate medical product packaging are specifically exempt from authorisation for continued use in these products.
• Are phthalates volatile? High Phthalates have a very low volatility. They are viscous liquids which bind tightly within PVC articles and have minimal migration under normal use, even in abraded particles that may be collected in the form of dust.
• What is known about the risks linked to a combined effect (sometimes incorrectly referred to as “cocktail” or “cumulative” effect)? This area of study is in its initial phase and the European Commission and several EU member states are currently examining this question in order to establish criteria and a robust scientific methodology which will form solid bases for studying this matter. The Commission is due to report to the European Environment Council on this topic in 2012.

• Plasticiser manufacturers and downstream users are aware of the market need to find alternatives for chemicals defined under REACH as “substances of very high concern”. However, under REACH, it is essential to be cautious and take the necessary time to evaluate the risks of these new molecules on health and the environment, as well as the technical and economic feasibility of changing to an alternative, before any switch is made in industrial applications.

• Phthalates account for 87% of the global market for plasticisers.
• 96% of plasticisers are used in soft PVC production for durable goods (cable, film, roofing, flooring or wall coverings, etc.).
• Only 4% are used in sensitive applications (medical devices, food packaging, toys), and these applications are all covered by specific European legislation to ensure optimal consumer and environmental safety.
• High molecular weight phthalates account for close to 80% of the European market for phthalates.
• Low molecular weight phthalates represent less than 11% of the phthalates used in Europe, and this figure has been falling steadily for more than 10 years.

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