{"id":9160,"date":"2019-01-11T08:00:16","date_gmt":"2019-01-11T14:00:16","guid":{"rendered":"https:\/\/www.ulprospector.com\/knowledge\/?p=9160"},"modified":"2022-02-25T08:42:55","modified_gmt":"2022-02-25T14:42:55","slug":"pe-are-pvc-additives-reach-compliant","status":"publish","type":"post","link":"https:\/\/ulprospector.ul.com\/9160\/pe-are-pvc-additives-reach-compliant\/","title":{"rendered":"Are PVC Additives REACH Compliant?"},"content":{"rendered":"

\"ComputerREACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a regulation of the European Union (EU), 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.<\/p>\n

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.<\/p>\n

REACH 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.<\/p>\n

\n

Questions about REACH?<\/h3>\n

Let our Regulatory Advisory Services guide the way! Lean on our expert advice to make sure your company is compliant.<\/p>\n

Learn more<\/a><\/h3>\n
\n

REACH outside the EU<\/h3>\n

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.<\/p>\n

Companies established outside the EU are not 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 a non-EU manufacturer established in the European Union.<\/p>\n

Nevertheless, 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).<\/p>\n

PVC additives<\/h3>\n

With REACH now established, the next step is to focus resources on enforcement, how does this affect additives for PVC?<\/p>\n

It\u2019s hard to think of a material that has been criticised more for its use of hazardous substances than PVC. Because of its role as a major consumer of chlorine, the polymer has been a key target of Greenpeace for over 20 years.<\/p>\n

Today, much of Europe\u2019s chlorine production still uses mercury cell technology, but PVC producers and additive suppliers in Europe have made steady progress on many of the other issues related to the PVC life cycle, such as increasing recycling rates and phasing out the most problematic additives.<\/p>\n

This has been driven by the sector\u2019s VinylPlus<\/a> 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 \u201chalogen-free\u201d policies of some big consumer brands (especially in the electronics sector).<\/p>\n

PVC and Additives<\/h3>\n

Before PVC can be made into products, it has to be combined with a range of special additives (compounding). These additives can influence or determine mechanical properties, weather fastness, colour and clarity and whether it can be used in a flexible application. The actual PVC polymer content in some applications can be as low as 25 percent by mass, the remainder accounted for by additives.<\/p>\n

PVC’s compatibility with many different kinds of additives is one of the material’s many strengths and is what makes it such a highly versatile polymer. PVC can be plasticised to make it flexible for use in wire and cable (the biggest market for flexible PVC), flooring and medical products. Rigid PVC, also known as PVC-U (the U stands for “unplasticised”) is used extensively in building applications such as window frames.<\/p>\n

Plasticisers<\/h3>\n

The selection of plasticisers depends on the properties required by the final product, and whether the product is for a flooring application or a medical application. There are more than 300 different types of plasticisers, around 50 of which have been registered since the implementation of REACH. Each company has the responsibility of registering their substances.<\/p>\n

The EU demand for plasticisers has been steadily shifting away from phthalates classified as carcinogenic, mutagenic, or toxic to reproduction (CMR), towards the many non-CMR plasticisers which today represent around 90 percent of all plasticisers being produced in Europe. A similar move away from CMR classified phthalates has occurred in North America, but in other areas of the world (e.g. China, India, and Latin America), CMR classified phthalates including diethylhexyl phthalate (DEHP) and dibutyl phthalate (DBP) continue to be produced and used to a high degree.<\/p>\n

Phthalates can be divided into two distinct groups with very different applications and classifications:<\/p>\n

Low Phthalates:<\/strong> Low molecular weight (LMW) phthalates contain eight or less carbon atoms in their chemical backbone. These include DEHP, DBP, diisobutyl phthalate (DIBP) and benzyl butyl phthalate (BBP). The use of these phthalates in Europe is limited to certain specialised applications.<\/p>\n

High Phthalates:<\/strong> High molecular weight (HMW) phthalates are those with seven – 13 carbon atoms in their chemical backbone. These include: diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), dipropylheptyl phthalate (DPHP), diisoundecyl phthalate (DIUP) and ditridecyl phthalate (DTDP). HMW phthalates are safely used in many everyday including cables and flooring.<\/p>\n

Speciality plasticisers<\/strong>: adipates, citrates, benzoates and trimeliltates are also used where special physical properties are required such as the ability to withstand very low temperatures or where increased flexibility is important.<\/p>\n

TOTM (Tris (2-Ethylhexyl) Trimellitate) is more suitable for high temperature compounds due to its lower volatility. These applications include wire and cable insulation (TOTM-CA) and interior automotive. TOTM has unique low migration properties and extraction resistance properties that are required for dishwasher gaskets and photograph storage. In some cases, TOTM is blended with other general-purpose plasticizers such as di(2-ethylhexyl) phthalate (DUP) or dioctyl terephthalate (DOTP) to lower volatility.<\/p>\n

PVC compounds intended for low temperature use might do better with plasticizers such as dioctyl adipate (DOA) or dioctyl sebacate (DOS) which retain low temperature flexibility better. Epoxidized Soybean Oil (ESO) is often used as a co-plasticizer and stabilizer, since it adds a synergistic improvement of thermal and photo-stability when combined with Ca\/Zn or Ba\/Zn stabilizers.<\/p>\n

Flame retardancy is a common requirement for wire and cable formulations. Plasticizers used such as phosphoric esters (i.e. Tri-N-butyl phosphate (TBP), trioctyl phosphate (TOF) can also impart flame retardant properties. Additives such as antimony trioxide (ATO) are effective flame retardants.<\/p>\n

Plasticizers in the wire and cable industry are often stabilized with a phenolic antioxidant in order to improve aging properties. Bisphenol A is a common stabilizer used in a range of 0.3 to 0.5% for this purpose.<\/p>\n

In the US, since 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.<\/p>\n

Chemical regulations are continually being evaluated, and phthalates are still in the spotlight. Since 2012, the US Environmental Protection Agency (EPA)\u2019s Phthalates Action Plan has been investigating eight phthalates: DBP, DIBP, BBP, Di-n-pentyl phthalate (DnPP), DEHP, Di-n-octylphthalate (DnOP), DINP, and DIDP.<\/p>\n

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.<\/p>\n

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 \u201cfood contact\u201d approval as an initial requirement for materials, whether or not their products are going into food packaging.<\/p>\n

Legacy additives<\/h3>\n

Legacy additives \u2013 those once legitimately used when the products were put on the market, but which are now restricted \u2013 are a barrier to PVC recycling. 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<\/strong><\/a> (SVHC)<\/strong> – and so recyclers need to know if their recyclate contains any SVHCs at a level above 0.1%w\/w.<\/p>\n

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. So if lead legacy additives are added to the authorisation list, products made from recyclate containing them could be phased out.<\/p>\n

Other additives used in PVC and covered by REACH include: <\/strong><\/p>\n