REACH registration for polymers is imminent
Photo: Public Domain Pictires
REACH registration for polymers is imminent – Europe will extend REACH registration to polymers. It is still unclear what the measures will look like and which polymers the registration relates to. What is clear is that the impact will be significant.
The Chemicals Strategy for Sustainability (CSS), which sets a new standard for safe and sustainable substances in Europe, has led to many far-reaching actions and the announced mandatory REACH registration of polymers is one of them. The CSS focuses on the principle of safe and sustainable design to stimulate innovation towards safe and sustainable substances and strengthen the competitiveness of the European chemical industry and make the continent more strategically independent in terms of critical raw materials and supply chains. First comes the notification (of all polymers), probably in 2024/25, and one to three years after that the registration (of a selection) has to take shape.
More clarity about security
REACH registration will bring more clarity to European citizens about the safety of polymers. “Most polymers are safe for their intended use,” said Nicholas Ball, toxicology consultant at Dow in Horgen, Switzerland. “Manufacturers already know a lot about safety in the production process due to the requirements for working conditions. But the potential risk in a broader sense – including microplastics and plastic waste – is still largely unknown. It’s about collecting data about things that are not yet known This aspect of transparency and knowledge gathering has positive sides for the industry. It can ultimately increase confidence in the industry and in polymers.”
Many cooperating agencies
How the registration will look like is still unclear. Those involved in the CARACAL group (authorities responsible for REACH and CLP) are still in intensive discussion about this. Everyone with their own ideas and plans. Cefic, the European Commission, industry, member states, NGOs and the European Chemicals Agency (ECHA) are represented in CARACAL. Together they must come to a legally valid text. In the process of finalizing the text of the regulation on behalf of the EU Commission, a lot still has to be coordinated. The same applies to acceptance by the member states.
The discussion is ongoing
A key question is: Which polymers are subject to registration? In fact, the only thing that is certain now is that natural, unmodified biopolymers such as cellulose, starch, protein, rubber and lignin do not have to be registered. There is a REACH definition of what a polymer is, but it does not automatically equate to what a polymer subject to registration is under REACH. “The discussion about this is still ongoing,” says Anniek Santing, Regulatory Affairs Manager at Covestro in Zwolle, the Netherlands. “We advocate limiting registration to polymers where there is a real risk of harm and to data that is really necessary for safety and transparency. Let’s not make this extra task harder than necessary for the industry. The good news is that industrial companies are working intensively towards this.”
What will be the guiding principles for selecting the estimated 2000,000 polymers to be polymers subject to registration (PRR)? “You can’t register all the different polymers, says Heli Hollnagel, regulatory toxicologist at Dow in Horgen, Switzerland. “Involved in the topic on behalf of Cefic. But which ones are and which ones aren’t? How do you prioritize? The tricky thing is that polymers are at the intersection of chemicals and materials. The registration concerns both the physical-technical and the toxicological properties. In addition to strict toxicological risks, there are also broader environmental impacts. This places considerable demands on the necessary tests.”
Safety data sheet
Santing further explains: “A registration dossier for a substance that is manufactured or imported in Europe therefore includes a description of the properties of the material and a series of toxicological tests. The industry decides among themselves who collects which data for which substance. The data on a Safety Data Sheet (SDS) taken together lead to certain conclusions about the effects on humans and the environment.”
There is great uncertainty as to how many polymers will receive PRR status. Santing (Covestro): “For us it would certainly be more than hundreds of polymers that we would have to register, but the final number depends very much on how things turn out.”
Group approach essential
Because of the sheer numbers, a group approach is essential. Ball (Dow): “Does PE, polyethylene, count as one polymer subject to registration, or do one hundred and fifty varieties count separately? If substances behave the same, can they be proposed in a data package for registration? This is one of our major concerns. ECHA has many guidelines for Grouping of substances under REACH. But how the interpretation will turn out is uncertain and strongly determines how much work companies will eventually have to do with registration.”
Still a lot of uncertainty
Hollnagel adds: “Registration potentially encompasses a wide range of properties. It is currently unclear which type of tests should be applied to which group of polymers. Based on existing knowledge and theory, you can state in advance that certain tests for certain (groups von) polymers are unnecessary. In the worst case, such tests are still required – at the expense of a lot of laboratory animal research.”
Role of substances not contained in the final product?
Another interesting question: Does the registration obligation also apply to primary and intermediate products, i.e. substances that are only used in the production process? And may a limited data set be supplied for this or does it have to be complete? Ball: “The position that substances that do not end up in the end product do not have to be registered is widespread. But that is not yet fully accepted. There is too little trust in how companies handle their materials.”
Advantage of European industry not clear
Citizens have an interest in knowing what risks may be associated with the use of certain polymers. Everyone agrees on that. But the European Commission’s claim that European industry will also benefit from registration? Ball: “If alternatives are needed for certain polymers, this would stimulate innovation. You can choose other monomers that lead to polymers that are more easily degradable or more easily recyclable. That shakes up the market, with winners and losers. But that spurs innovation We also now understand that one polymer with high barrier properties is better than sixty layers of different material in a bread bag.” According to Hollnagel, the registration requirement can create a barrier against new types of sustainable polymers. “How should companies prepare for unknown registration rules in five or eight years? So no, we don’t see that benefit.”
About “The Blacksmith’s Secret”
Another relevant aspect of registration concerns the “forge secret”. Hollnagel: “Suppose two competitors both produce the same polymer. Of course, everyone does it a little differently. If you then share the registration obligations, how do you keep your business secrets, which bring a certain benefit to your customers, to yourself?” Do you share just the ingredients or the whole recipe?
Concerns about customers
Speaking of customers, Hollnagel is very worried about them: “Customers build their own polymers from the chemical building blocks we supply. It will be difficult for smaller customers to keep up with commitments, let alone carry out all the work, to meet them.”
The importance of a level playing field
A global level playing field is also important, says Ball. “Measures should strengthen European industry and not add an additional layer of government that encourages companies to invest outside of Europe.”
What about imports?
Polymers that have been registered by the correct party and meet applicable compositional requirements may be imported into Europe. But what about importing finished products? Santing: “I see the danger that REACH applies to polymers and not to parts made of polymers. If end products with parts or housings that require approval in Europe can simply be imported, that’s a problem.”
Registration preparation important
Nevertheless, she considers it important to prepare for the registration despite all the ambiguities: “We gear our product responsibility to this and provide input that can contribute to a meaningful drafting of the legislation. You want your materials to be safe and therefore need to know what they contain. One can only hope that a good selection takes place and that the regulations remain workable in practice.”
What makes registration so difficult?
“When you make a certain type of polymer, you always end up with a mixture of different molecules,” says Henk van den Haak of ResinConsult, which specializes in polymer training and consulting. “In your reactor, you’re threading strings of the same ‘pearls’, so to speak. One string gets much longer than the other in the same amount of time. In fact, all these molecules with chains of different lengths are different substances. All these substances together form a tangle, the what we call a polymer. Also, if you make a polymer out of different beads, you quickly end up with a billion or more different substances.”
Under REACH it was sufficient to demonstrate that a substance was a polymer to be exempted from registration. “It wasn’t easy at all,” says Van den Haak. “To be considered a polymer, a fabric had to be at least fifty percent by weight chains of at least three ‘globules’ or monomers. Within the paint world, manufacturers keep the chains as short as possible. Because of the variation described above, chain length was often at the Limit of definition. It took a lot of calculations to get that right. But that’s no longer the case now that polymers have to be registered too.”
The big question
The big question is: what definition or principle should the registry be based on? Van den Haak: “This requires an overarching and above all practicable construction, but that is not there yet.”
How many polymers?
A group of scientists (from the fields of polymer chemistry, ecotoxicology, environmental chemistry, conservation biology, environmental science, marine biology, air pollution, food packaging and sustainability assessment) realized in 2021 that not enough is known about polymers. The group supported the need for registration under REACH. But also noted that “According to the criteria described in the Wood/PFA report (which, on behalf of the European Commission, proposes criteria for identifying polymers subject to registration – ed.) only about 6 percent of the estimated 200,000 polymers on the EU market can require registration. While most polymers – which are used in the largest quantities and are a major contributor to the current plastic crisis and increasing pollution from micro- and nanoplastics – do not require a registration procedure are polystyrene, polyvinyl chloride, polyethylene terephthalate and polyamide.
A very slow process
The European Commission is now assuming 30 percent. Assuming 200,000 polymers, that would be 60,000 PRR. To show how big the registration challenge is: Since the introduction of REACH in 2007, around 23,000 registration dossiers have been submitted.
Also Read: New pharmaceutical IUCLID datasets support alternatives to animal testing
This information has been compiled with the greatest possible care, in some cases from different information sources. (Interpretation) errors are not excluded. No legal obligation can therefore be derived from this text. Everyone dealing with this subject has the responsibility to delve into the matter!