REACH

How is REACH addressing plasticisers?

REACH (Registration, Evaluation, Authorisation and Restriction of CHemicals) 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.

Registration of plasticisers

With respect to plasticisers (US: plasticizers), 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 orthophthalates DINP, DIDP and DPHP, which all are not classified according to the EU CLP, and also the classified orthophthalates 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 (US: plasticizers) such as acetylated glycerol esters, epoxidized soy bean oil and alkyl phenol esters of sulphonic acid have also been registered. View the list of plasticisers

Evaluation of plasticisers

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.

Authorization of plasticisers

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 an application by producers, importers or users 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. It should be noted that an Authorisation for use is specific to the companies requesting the Authorisation and is time limited.

Eleven LMW orthophthalates, 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 (and the remaining seven are being proposed for the Candidate List). This means that after the sunset date of February 21st 2015, the four LMW orthophthalates (DEHP, DBP, BBP and DIBP) can be placed on the EU market only for those uses for which an authorisation has been granted to specific applicants.

Applications for Authorisation for DEHP and DBP have been made by some companies and the ECHA Risk Assessment Committee (RAC) and the Socio-Economic Committee (SEAC) are recommending Authorisation for specific PVC and other applications, for three companies and also recommending Authorisation for recycling for three different companies. For PVC applications the recommended time for Authorisation is 4 years i.e. new phase out date is February 2019. These recommendations are subject to confirmation by the European Commission. If a decision is not made by the European Commission by February 2015, then DEHP and DBP can continue to be placed on the market by those companies seeking Authorisation until such time as a decision is made. A final Commission decision on the PVC and Polymer applications is expected in 2015.Since no applications for Authorisation have been made for BBP and DIBP these substances can no longer be used for uses coming under the scope of REACH as of February 21, 2015 i.e. they are phased out. The production of the remaining seven low molecular weight plasticisers (US: plasticizers) had already been voluntarily stopped by their European producers prior to their inclusion in the REACH Candidate List.

The first application by Rolls Royce for the use of DEHP in the manufacture of aircraft turbines has been confirmed by the European Commission following a positive opinion from ECHA’s RAC and SEAC. The Authorisation for this use is specific to Rolls Royce and is for seven years i.e. re-Authorisation will be required after seven years with the application due 18  months before the new phase-out date.

Restrictions relating to plasticisers

As well as being subject to Authorisation, the classified orthophthalates (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 under the Cosmetics Directive.

Regarding the non-classified orthophthalates, some of them are restricted only in a very specific application 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. All relevant hazard data, including reproductive and endocrine data, was also evaluated and documented with the exposure information in a report of 370 pages involving review of 384 peer reviewed scientific publications and reports. The main endpoint for which a “risk cannot be excluded” is mild liver effects seen at high doses in rat studies. 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).

What’s the future of plasticisers

The EU demand for plasticisers has been steadily shifting away from CMR (carcinogenic, mutagenic or toxic to reproduction) classified phthalates towards non-CMR classified phthalates and other non-CMR classified plasticisers which today represent around 95% 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, Middle East, Africa and 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.

 

EU RISK ASSESSMENTS

Five phthalate plasticisers (US: plasticizers), DINP, DIDP, DEHP, BBP and DBP have been subject to comprehensive European Union Risk Assessments conducted under European Union Regulation 793/93. This legislation, which has now been replaced by the EU chemicals legislation REACH, sets out a framework for the evaluation of the risks which substances may pose to human health and the environment.

Under the EU Regulation 793/93, the risk assessments for substances were prioritised according to production volumes. For each prioritised substance, experts from one national EU government volunteered to draft its assessment. In each case the rapporteur country worked together with other EU Member States experts, industry and third parties to collate data in order to draft a risk assessment report. The European Chemicals Bureau coordinated the risk assessment process.

Following this, Risk Assessment Reports were peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment, which is the European Union's highest source of independent scientific advice, giving its opinion to the European Commission on the quality of risk assessments.

Conclusions of the Reports

After analysing the Risk Assessment Report, national experts either maintained that no further measures to protect human health or the environment were necessary, or proposed measures to be taken to reduce any risks determined by the report.

National EU governments and the European Commission agreed upon the conclusions which were subsequently published in the Official Journal of the European Union and on the European Commission's Joint Research Centre website.

OECD

The EU Risk Assessment Reports were also presented to the Organisation for Economic Co-operation and Development as a contribution to Chapter 19 of the Agenda 21 goals for evaluating chemicals, agreed at the United Nations Conference on Environment and Development, held in Rio de Janeiro in 1992.

The risk assessment reports, summary reports and announcements in the EU Official Journal are available on the following web pages:

High molecular weight phthalates: DINP, DIDP 

Low molecular weight phthalates: DEHP, BBP, DBP