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REACH is the EU’s major regulation for chemicals involving the registration and evaluation of the thousands of chemicals which are used in many everyday products and articles which are placed on the European Union market, both those manufactured in the EU as well as those which are imported. REACH is the most comprehensive product safety regulation anywhere in the world, and is supporting the safe use of chemicals in the European Union. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.
With respect to plasticisers, over the last 60 years more than 30,000 different substances have been evaluated for plasticising properties. Of these only a small number have survived the rigorous performance, cost, availability and health and environmental requirements which are imposed by the market including by users and regulation. Since the implementation of REACH in 2007, more than 50 plasticisers have been registered.
Registered primary plasticisers include the ortho-phthalates DINP, DIDP and DPHP, which all are not classified according to EU CLP, and also the classified ortho-phthalates DEHP, DIBP, DBP and BBP. Further, other plasticizers like the terephthalates DBT and DOTP as well as those belonging to other chemical classes. such as adipates, benzoates, di-benzoates, cyclohexanoates, citrates, sebacates and azelates have already been registered. Several secondary plasticisers such as acetylated glycerol esters, epoxidized soy bean oil and alkyl phenol esters of sulphonic acid have also been registered.
REACH involves evaluation at a number of levels including dossier evaluation, evaluation of testing proposals, evaluation of classification and also substance evaluation. Several low molecular weight phthalates (LMW) had been previously classified for reproductive effects and under REACH two additional LMW phthalates have been classified as Category 1B reproductive agents (Di-isohexyl phthalate and Di-n-hexyl phthalate). With respect to substance evaluation this process involves a 3 year Community Rolling Action Plan (CoRAP 2014-2016) which now includes a total of 120 substances. Several plasticisers are listed on the CoRAP including DEHA, DTDA, L79P, DPHP, L911P, L11P, DIUP, DTDP, DIDAz and will be subject to evaluation by a Lead Member State during the assigned year. Draft conclusions will be subject to agreement by the ECHA Member State Committee.
Substances which are identified as substances of very high concern are placed on the REACH Candidate List and then prioritized for inclusion in the REACH Authorisation List (Annex XIV of REACH). These substances are then subject to application for Authorisation for specific uses, at least 18 months ahead of the sunset or phase-out date. The Authorisation dossier to be submitted has to include a demonstration of adequate control (risk management) for substances with a threshold or demonstration of socio-economic need and lack of alternatives for substances without a threshold.
Nine LMW phthalates, classified as Category 1B reproductive agents have been identified as Substances of Very High Concern (SVHC) and placed on the REACH Candidate List. Four of these substances, DEHP, DBP, BBP and DIBP, are on the Authorisation List. This means that after the sunset date of February 21st 2015, these substances can be placed on the EU market only for those uses for which an authorisation has been granted to specific applicants. If a decision is not made by the European Commission by February 2015, then the plasticisers can continue to be placed on the market until such time as a decision is made. The production of the remaining five low molecular weight plasticisers had already been voluntarily stopped by their European producers prior to their inclusion in the REACH Candidate List.
ECHA has received seven applications covering uses of DEHP and DBP. Since no applications for BBP and DIBP have been submitted, their use in the EU will therefore be phased out by the sunset date.
So far, the first application for use of DEHP in the manufacture of aircraft turbines has received a positive opinion (with proposal for Authorisation for seven years) from RAC and SEAC who will develop their opinions on the Authorisation applications for PVC and polymer applications by September 2014. A final Commission decision on the PVC and Polymer applications is expected in 2015.
As well as being subject to Authorisation, the classified phthalates (DEHP, DBP, BBP) are restricted in all toys and childcare articles (limit of 0.1% by weight). The classified phthalates, as Category 1B reproductive agents, are also restricted in cosmetic products.
Regarding the non-classified phthalates, some of them are restricted only in very specific applications as it is the case for DINP and DIDP in toys and childcare articles which can be placed in the mouth. On January 2014, the European Commission published its conclusions regarding the re-evaluation of the restrictions on DINP and DIDP indicating that “no unacceptable risk has been characterised for the uses of DINP and DIDP in articles other than toys and childcare articles which can be placed in the mouth”. The ECHA report covered an assessment of potential exposure to DINP and DIDP from all sources, including indoor air and dust, food, clothing, vinyl flooring, vehicle interiors and other sources. This has enabled the Commission to reach a conclusion on the lack of risk from all current consumer applications.
Few substances have been subject to the level of comprehensive evaluation conducted by ECHA on the non-classified phthalates, DINP and DIDP. This outcome should provide reassurance to consumers, as well as a stable regulatory environment for companies using these general purpose plasticisers. Further details can be found here.
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 European plasticisers industry is strongly committed to the safety and sustainability of its products and their full compliance with REACH and other EU regulations. Do not hesitate to contact ECPI if you need further information.