ECHA

Implementing REACH requires a lot of communication within the supply chain, which is not always practical due to the legitimate business concerns of different parties. Geoffroy Tillieux, Director of Regulatory Compliance at Polymer Comply Europe, gives his views.
 

Geoffroy Tillieux,  Director of Regulatory Compliance at Polymer Comply Europe. Image: Geoffroy Tillieux.

Legitimate business concerns

One such concern is the spread of proprietary knowledge. When downstream users need to give their suppliers a process description, it is not necessarily in their interest to provide in-depth details on how the substance is used. As the commercial interest of substance producers is to supply as much as possible, they could decide to release this process description to the downstream user’s competitors. The interests of manufacturers and downstream users are then not always fully aligned.

On the other hand, downstream users are getting more familiar with REACH and are realising how vital it is for registrants to have a detailed process description, to show how a substance can be used safely and avoid regulatory risk management measures. Another issue is that SMEs may generally have a limited knowledge on European chemicals legislation. Although frequently stated to be a poor excuse for non-compliance, this is actually an issue that deserves more attention. These matters can have significant consequences for companies, especially when critical substances enter certain REACH processes (e.g. authorisation).

Companies that do not communicate their use in enough detail may find that registrants are unable to produce a detailed enough risk assessment to convince authorities of the need for an exemption in a restriction procedure. Businesses, especially SMEs, could find themselves overwhelmed by an authorisation requirement that they could have seen coming years in advance if they had sufficient knowledge about REACH.

Working together towards a solution

There is great potential for industry associations to contribute, both in communicating use descriptions and disseminating knowledge. The associations can bundle resources and better understand the detail needed by their members to help fulfil their obligations.

One such initiative by producers, formulators and end users is the Anhydrides Joint Industry Taskforce (AJIT), founded in December 2015.

The purpose of AJIT is to:

• gather information on current exposure levels and risks associated with anhydrides and propose protective measures;
• evaluate socio-economic impacts of an authorisation; and
• inform authorities of possible risk management options for the use of anhydrides.

Hexahydrophthalic anhydride (HHPA) and methylhexahydrophthalic anhydride (MHHPA) are respiratory sensitisers and have been identified as substances of very high concern (SVHCs) that may be subject to authorisation in the future. It is therefore critical for their use to be well documented in the registration dossier and that end users are well informed about the procedure.

AJIT identified two epoxy uses where the anhydride functions as a monomer in a polymerisation reaction to produce articles (electrical insulation): high voltage rotative devices (i.e. motors and generators) and switch gears. The use of those substances is strategic to ensure continued power generation and distribution in Europe as well as enabling transport of people and goods. Their use is a result of improving costs, performance and durability over the last decades. There are currently no satisfactory substitutes, as products do not reach the required durability for outdoor use or an adequate electrical performance. One of AJIT’s first actions was to reach out to all epoxy users of HHPA and MHHPA.

AJIT’s immediate task was to respond to a public consultation. Within months, it had collected all available information from public sources and member companies on the use of the substances, as well as exposure information, any known cases of adverse health effects and socio-economic information. These were submitted in a public consultation report.

Since then, AJIT has developed an outreach programme whereby any interested company can join a two-hour webinar where the regulatory process is explained, the current status of the anhydrides is clarified and questions are answered by an expert. Furthermore, under the guidance of Polymer Comply Europe, the service company of the European Plastics Converters Trade Association, which provides the secretariat, coordination and supervision of the scientific and outreach activities to AJIT, working groups of experts in the epoxy use of anhydrides were set up.

Using ECHA’s use descriptor system, they produced detailed process descriptions of their uses. These have been provided to registrants, who have been incorporating them into their registration dossiers.

Additionally, all AJIT members have:

• voluntarily committed to measure exposure related to the different process steps and formulate exposure minimisation measures based on continuous improvement;
• developed a medical diagnostic guideline for early detection of any adverse health effects related to the use of the substances;
• created a training programme for workers on how to work with anhydrides; and
• reported on the progress of the voluntary commitment implementation in a transparent manner in an annual progress report.

Many companies using anhydrides operate in the electrical industry and perceive the work of AJIT as an eye opener, not just to their duties, but also to the strategic objectives that REACH aims to fulfil. As specialists from the electrical industry were mostly familiar with other pieces of EU legislation, they saw developments under REACH as a threat to fulfilling the strategic objectives of resource efficient power generation and distribution.

More specifically, the eco-design directive that mentions that electrical equipment used to generate, distribute and use electricity should be as efficient as possible – which would be a challenge without HHPA and MHHPA as they are used to produce material with superior electrical insulation properties and essential for generators, switch gears and motors. These experts nevertheless realise that the targets under REACH are valid aspirations set by the EU and they are committed to both strategic EU objectives: ensuring the highest levels of energy efficiency while protecting health and the environment.

Geoffroy Tillieux is the Director of Regulatory Compliance at Polymer Comply Europe SCRL (PCE). He has been working for the European Plastics Converters Association since 2000 and at PCE since 2005. He coordinates plastics and raw materials issues including recycled materials, food contact issues and development of compliance tools, risk assessments and consortia related to implementing REACH.

The Anhydrides Joint Industry Taskforce (AJIT) represents producers, importers, formulators, and end users of the anhydrides HHPA and MHHPA. These anhydrides may fall under authorisation in the future.

Further information:

The Anhydrides Joint Industry Taskforce (AJIT)

Published on: 13 September 2018

Top image: The Anhydrides Joint Industry Taskforce
 

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