The EU REACH regulation aims to improve human health and environment. Andy Pye looks at its application to PVC additives.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years.

The regulation also established the European Chemicals Agency, which manages from Helsinki, Finland, the technical, scientific and administrative aspects of REACH. It requires all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances. Any company importing goods into Europe could also be affected.

The European Chemicals Agency set three major deadlines for registration of chemicals, mainly determined by tonnage. 1000tpa lots were required to be registered by 1 December 2010, 100tpa by 1 June 2013 and 1tpa by 1 June 2018. In addition, chemicals of higher concern or toxicity had to meet the 2010 deadline.

Non-compliance concerns

With REACH now established, the next step is to focus resources on enforcement. The European chemical industry claims that an absolute majority of the substances used on the market has been successfully registered by the deadline and that the chemical industry will continue supplying its markets and customers with no disruptions.

However, as recently as October 2018, controversy surrounded the implementation of REACH. A study, carried out by the German Federal Institute for Risk Assessment (BfR) and Environment Agency (UBA), investigated more than 3800 dossiers submitted across the EU. Some 32% of substances at tonnage levels of 1,000tpa and above were found to be non-compliant.

"The non-compliance is there because the data is not there, but (the substance) is on the market," said Bas Eickhout, a Dutch MEP and member of the GreenLeft. "The member states do know it. What are they going to do to those companies who are non-compliant?"

German Green MEP Martin Häusling called the compliance study findings a "scandal" for the chemicals industry. There are more than 600 chemicals on the European market without proper checks, he said.

The European Chemical Industry Council (Cefic) says the data gaps are partly due to confusion about non-animal testing methods - one of the objectives of REACH.

Global applicability

The reach of REACH is not limited to countries inside the EU. Many regulations which are formulated in a major trading block extend their influence beyond its borders - the US Food and Drug Administration (FDA) regulations are a case in point.

And so, while the EU chemical industry is looking principally to the EU member states to make sure REACH becomes a competitive advantage for the European industry, its sphere of influence is much wider.

The EU is a global player – a global rule maker – able and willing effectively to impose extra-territorially its values, rules and standards. EU projects power, probably more effectively than Washington, in multiple critical regulatory areas – and uses its pooling of internal sovereignty to impose its values and standards well beyond its borders.

REACH is the strictest law to date regulating chemical substances and will affect industries throughout the world. On 8 June 2006, the REACH proposal was criticized by non-EU countries, including the United States, India and Brazil, which stated that the bill would hamper global trade.

Outside the EU

While companies established outside the EU are not directly bound by the obligations of REACH, even if they export their products into the customs territory of the European Union, the responsibility for fulfilling the requirements of REACH lies with the importers established in the European Union, or with the representative of any non-EU manufacturer established in the European Union.

Many countries outside the European Union are also implementing REACH-regulations or are in the process of adopting such a regulatory framework, in order to move towards a more globalized system of chemicals registration under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Balkan countries such as Serbia (and Croatia prior to its accession to the EU) adopted the EU REACH system under the auspices of the EU IPA programme. Switzerland moved towards implementation of REACH through partial revision of the Swiss Chemical Ordinance on 1 February 2009. The new Chemicals Management Regulation in Turkey is paving the way for the planned adoption of REACH in 2013.

Outside Europe, China has moved towards a more efficient and coherent system for the control of chemicals in compliance with GHS. In the US, chemical regulations are continually being evaluated, and phthalates, used as PVC additives is an example of chemicals which are in the spotlight.

Brexit implications of REACH

According to Silvia Segna, representative of the UK Chemicals Industry Association (CIA), the UK will have a major task ahead if a decision is taken to transpose REACH into UK law, as a consequence of Brexit.

“Copy paste is not possible where REACH is concerned, because some laws just cannot be directly copied in UK law. Some changes will certainly have to be proposed by the UK government, using secondary legislation”, she said. A public enquiry into REACH by the House of Commons in the UK sought to examine this and concluded that further work will need to be done to ensure that chemicals imported into Europe meet Europe’s high standards for health and environmental safety. Meanwhile, CIA is advocating that the UK pay if necessary in order to still maintain their participation in REACH. The ultimate priority is tariff-free access to the EU’s single market, plus regulatory consistency.

PVC and REACH

It’s hard to think of a material that has been criticised more for its use of hazardous substances than PVC (polyvinyl chloride). Because of its role as a major consumer of chlorine, the polymer has been a key target of environmental groups for over 20 years.

Today, much of Europe’s chlorine production still uses mercury cell technology, but steady progress has been made by PVC producers and additive suppliers in Europe on many of the other issues related to the PVC life cycle, such as increasing recycling rates and phasing out the most problematic additives. This has been driven by the sector’s VinylPlus voluntary programme, which was launched in 2000 in a (successful) bid to fend off legal restrictions on PVC from the European Commission, and which continues to be driven by pressure from Greenpeace and other NGOs, and the “halogen-free” policies of some big consumer brands (especially in the electronics sector).

For Europe’s PVC industry, the continuing focus on the plastic’s environmental record is both a curse and a boon. Although REACH does not (so far) require the registration of polymers, all of the stabilisers, plasticisers, fillers, pigments and other additives in PVC must be registered, and some of these have been added to the candidate list and are subject to authorisation or restriction, ensuring a steady drip-feed of bad news and supply chain reformulation work.

But the same regulatory requirements also offer the industry a chance to rebrand today’s PVC as an example of what REACH is all about – reducing the toxicity footprint of those materials and products that are important to Europe’s economy. Given the European PVC sector’s inability to compete with other regions of the globe on cost, it needs to find its niche elsewhere and “green” plastics is an area where it is taking a lead.

Additives for PVC

Before PVC can be made into products, it is combined with a range of special additives. These additives can influence or determine its mechanical properties, weather fastness, its colour and clarity and indeed whether it is to be used in a flexible application. This process is called compounding. The actual PVC polymer content in some applications can be as low as 25% by mass, the remainder accounted for by additives.

PVC can be plasticised to make it flexible for use in many areas. Rigid PVC, also known as PVC-U (the U stands for "unplasticised") is used extensively in building applications such as window frames.

Many of the PVC products used daily contain phthalate plasticisers - everything from lifesaving medical devices such as medical tubing and blood bags, to footwear, electrical cables, packaging, stationery, and toys. In addition, phthalates are used in other non-PVC applications such as paints, rubber products, adhesives and some cosmetics.

Since the implementation of REACH in 2007, more than 50 plasticisers have been registered. The selection of plasticisers depends on the final properties required by the final product, and the application itself – for example, if it is to be used in flooring or a medical application.

The EU demand for plasticisers has been steadily shifting away from CMR (carcinogenic, mutagenic or toxic to reproduction) classified phthalates towards the many non-CMR plasticisers which today represent around 90% of all plasticisers being produced in Europe.  A similar move away from CMR classified phthalates has occurred in North America, but in the rest of the world (China, India, Latin America) CMR classified phthalates including DEHP and DBP continue to be produced and used to a high degree.

The most commonly used plasticisers are phthalates which can be divided into two distinct groups with very different applications and classifications:

• Low Phthalates: Low molecular weight (LMW) phthalates contain eight or less carbon atoms in their chemical backbone. These include, DEHP, DBP, DIBP and BBP. The use of these phthalates in Europe is limited to certain specialised applications.
• High Phthalates: High molecular weight (HMW) phthalates are those with 7 - 13 carbon atoms in their chemical backbone. These include: DINP, DIDP, DPHP, DIUP and DTDP. HMW phthalates are safely used in many everyday including cables and flooring.
• Speciality Plasticisers: such as adipates, citrates, benzoates and trimeliltates are used where special physical properties are required such as the ability to withstand very low temperatures or where increased flexibility is important.

Since 2012, US Environmental Protection Agency (EPA)’s Phthalates Action Plan from 2012 is investigating eight phthalates (DBP, DIBP, BBP, DnPP, DEHP, DnOP, DINP, and DIDP).  In 2016, a coalition of NGOs submitted a petition to FDA requesting that FDA delist phthalates from food regulations; these substances would not be able to be used in any food-contact materials.

Although several of these products are no longer used commercially in the US, a few currently have important commercial uses, such as flexible medical compounds plasticized with DEHP. Many US manufacturing companies view “food contact” approval as an initial requirement for materials, whether or not their products are going into food packaging.

Virtually no PVC in the US is produced using mercury cell technology, lead stabilisers have been largely replaced with mono-tin ones, and DEHP is only used for medical devices such as blood bags. As a result, the organisation does not need a voluntary programme in the mould of VinylPlus.

Legacy Additives

A potential barrier to recycling PVC is the presence of legacy additives – those once legitimately used when the products were put on the market, but which are now restricted - in discarded long life products. There is a requirement under REACH to provide an extended safety data sheet for any substance or preparation containing a substance of very high concern (SVHC) - and so recyclers need to know if their recyclate contains any SVHCs at a level above 0.1%w/w. EUPR, the European Plastics Recyclers Association, has produced a tool which enables recyclers to produce eSDSs.

REACH also requires companies to tell end users or consumers whether their products contain any SVHCs above the 0.1% threshold, and this means firms producing products made from recycled PVC must declare that their products contain SVHCs unless they can show that they are present at levels below the threshold. But despite the lead stabiliser phase-out, recycled PVC can easily contain lead compounds above the threshold, and so if lead legacy additives are added to the authorisation list, products made from recyclate containing them could be phased out.

**************************************

Sources of Information

REACH and other regulations affecting the use of PVC (Powerpoint)
Chris Howick, Chair, ECVM REACH Task Force
http://www.iom3.org/fileproxy/299480

Chemical Inspection and Regulation Service (CIRS)

*******************************************