legislation feature | Understanding REACH
A few restrictions may also be adopted this year, including for lead, mercury and DMFu.
6. Classification and labelling Requirements for notification to ECHA of classification and labelling entered into force in January 2011. It took one year for ECHA to release its inventory (
http://bit.ly/REACHdata). The discrepancies in classifications of the same substance was surpris- ingly high, which has caught the interest of regula-
tors; further discussions or actions are expected later this year. In 2012, the authorities will also continue the
Denmark is adding further complications to issues surrounding phthalate plasticizers for PVC
Commission finally settling their disagreement on the application of the 0.1% threshold, which triggers the information requirement for substances in complex articles. Most Member States, the Commission, and ECHA argue that it applies to a whole complex article, for example a car, while six Member States and Norway consider that it applies to each and every individual part of the complex article, based on the principle ‘once an article - always an article’ (1O5A). The General Court might render a decision in pending challenges to the inclusion of anthracene and pitch, and coal tar (high temp.) on the Candidate List. Important arguments before the Court relate to the infringement of procedural rights of industry in the absence of review of alternatives or classification as PBT or vPvB based on the properties of the constituents of the substance.
5. Authorization, restriction and regulatory overlap The first application deadlines under the REACH authorization regime will be August 2013, which will apply to four major plasticizers (DEHP, BBP, DBP and DIBP). This is an onerous and time-consuming process and many companies will be busy preparing them this year. The first applications are expected already this year. In the case of phthalates, the task is seriously
complicated by Denmark, which submitted a draft restriction proposal currently under public consultation for these four phthalates in products for indoor use or that may come into contact with skin or mucous membranes. Though restriction of substances subject to authorization is encouraged by REACH, better coordina- tion is necessary to avoid legal uncertainties and unnecessary burdens on companies preparing authori- zation applications. Denmark is also moving forward with its own national ban of these four phthalates. In addition, ECHA’s third recommendation on inclusion of substances on the Authorization List will be processed, and possibly adopted, this year.
20 COMPOUNDING WORLD | April 2012
process of adopting harmonized classification and labelling. There are currently four ongoing public consultations, including bis(2-ethylhexylmercaptoac- etate), DMT (EHMA) and Dimethyltin dichloride (DMTC). These substances are used as heat stabilisers in PVC. The proposed hazard classes are acute toxicity, skin corrosion (DMTC), skin irritation (EHMA), reproductive toxicity, and STOT - repeated exposure. The deadline for comments for these two substances is 30 March 2012.
7. eSDS Electronic safety data sheets (eSDSs) have been criticized for being overly lengthy and complicated. This year will hopefully see agreement on practical solutions for these problems. New SDS requirements for substances and some mixtures will be triggered as of 1 December 2012.
8. Emerging Issues European authorities are moving closer to agreement on additional requirements for nanomaterials. A new non-binding definition was adopted last year, while a requirement under a draft Biocidal Products Regulation is to be approved shortly by the European Council. In addition, SCCS safety assessments of nanomaterials in cosmetics will take effect in 2012. ECHA also plans to review its guidance on informa-
tion requirements and chemical safety assessments to reflect the results of RIP-oN 2 and 3. The two RIP-oN projects cover (i) information requirements and (ii) exposure assessment and hazard/risk characterization for nanomaterials, respectively. It should be noted that there is no intention to review the guidance based on RIP-oN 1 on substance identification. The Commission recently released a state-of-the-art
assessment on endocrine disruptors, which is available at:
http://bit.ly/REACHendocrine. This report may lead to additional regulation and restrictions of these substances. It will possibly feed the discussion on what a substance of equivalent concern is, which is a
www.compoundingworld.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70
