By Eleanor Grimes, PhD
A recent REACH amendment has updated Entry 51 to cover a wider range of phthalates and articles. This amendment – which was published at the end of last month – is to be implemented on 7th July 2020.
Entry 51 Annex XVII
Entry 51 in Annex XVII of REACH outlines the conditions in place restricting the usage of specific phthalates in plasticised materials.
Initially, this just covered three specific phthalates and their usage in toys and childcare articles; however, this recent amendment has updated the entry to cover a wider range of phthalates and articles.
What are Phthalates?
Phthalates are commonly used plasticisers in toys and a wider variety of other products. Due to their prevalence in modern life, and the ability to be exposed to them via all three major routes (oral, inhalation and dermal) various studies have been done to determine their safety.
This has led the RAC (Risk Assessment Committee) and the SEAC (Socio-Economic Analysis Committee) to propose amendments to the REACH regulation.
What does the amendment cover?
Initially, only Bis (2-ethylhexyl) phthalate (DEHP CAS 117-81-7), Dibutyl phthalate (DBP CAS 84-74-2), and Benzyl butyl phthalate (BBP CAS 85-65-7) were restricted. However, due to its similar hazard profile, Diisobutyl phthalate (DIBP CAS 84-69-5) is also now to be included within the restriction.
The restriction has also been re-worded so that it covers the phthalates both individually but also in combination with each other, a practice which is common in the synthesis of materials such as polyvinyl chloride (PVC) and polyurethanes.
It also covers articles in a more general sense rather than only toys and childcare products, although exemptions are still in place, covering items such as food packaging, articles used in aircraft and motor vehicles, and articles placed on the market prior to 7th July 2020.
REACH for Articles Online Training
Our popular Online Training Course, REACH for Articles, has been carefully designed to cover the requirements for Articles under REACH.
Furthermore, we’ve got an EXCLUSIVE OFFER. All of our 2019 Training Courses are currently being offered at a DISCOUNTED PRICE.
Never Miss an Update!
UL’s global Regulatory Assurance Team contains more than 50 regulatory analysts worldwide, serving customers in six continents, with multi-lingual support in more than 30 languages. Our team can help you navigate the complex, ever changing regulatory landscape to understand and execute your compliance obligations.
For all of the latest regulatory news and the most important industry updates, sign up to our fortnightly Regulatory Round-Up Newsletter.