REACH is the European Union regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals. The regulation entered into force on 1 June 2007 and is uniformly and directly applicable in all the member states of the EU. The focus of REACH is on materials that are harmful to health or the environment. These materials are generally referred to as Substances of Very High Concern (=SVHC). Only chemical substances that have previously been registered may be placed on the market. The organisational and administrative aspects of the regulation are managed by ECHA (European Chemicals Agency) in Helsinki.
Role in IMDS
Article 33 of REACH ordinance (EC 1907/2006) regulates the duties to report materials in products within the supply chain and to the private consumer.
Information on substances of very high concern, which are listed in the REACH Candidates List, must automatically be reported to the recipient of a product, if one of the substances is present in the product in a higher concentration than 0.1% of the total weight.
The REACH Candidates List is updated twice a year. With each update, the component manufacturers are required to check their material data sheets in IMDS to ascertain whether one of the substances on the MDS, which was previously hidden using a wild card or was classified as confidential, is now listed on the Candidates List. If so, then the manufacturer must send an updated material data sheet to its customer. The IMDS system itself checks all the data in the database as soon as the Candidates List is updated and informs the concerned company administrator in case material data sheets need to be updated. The manufacturer, however, must manually check its material data sheets and ascertain whether materials that were hidden using wild cards are now listed on the Candidates List. If so, then the material must be named and the material data sheet must be resubmitted.
Most of the relevant substances on the Candidates List are also added to the GADSL (Global Automotive Declarable Substances List). These materials can no longer be marked as confidential and may not be hidden behind wild cards.
Different reporting requirements must be met with regard to REACH and SVHC. Article 33 of the REACH ordinance regulates the obligation to report within the supply chain and also to the end customer. Manufacturers of products (referred to as "parts" in IMDS) must fulfil their obligation to inform the recipient in case one of the substances listed on the REACH list is present in the product in a higher concentration that 0.1% of the product weight. In such a case, all the downstream members of the supply chain must be informed immediately by naming the substance. If required, information about safe handling must also be provided. Under Article 34, the user is in turn obliged to report if they receive new information on one of the substances.
Consumers have the right to demand and be informed about the SVHCs in products on request. The German Federal Environment Agency has provided sample letters for requests on its website (keyword "New reporting duties for companies" dated 28 October 2008). Companies are obliged to respond to these requests within 45 days, by naming the substance and, if required, providing information about its safe handling.
SVHC basic substances in IMDS
As mentioned earlier, the REACH list is updated twice a year. In the IMDS tree structure, the SVHC basic substances are shown as underlined. It is also possible to search material data sheets manually for these materials using the Evaluation function ("Where-used List").
Assistance to companies
To assist the companies, in particular small and medium-sized companies (SMEs) in fulfilling the requirements of the regulation, technical guides, so-called RIPs (REACH Implementation Projects), as well as state information offices have been made available to the member states in addition to the materials published by ECHA. The national Help Desk in Germany has been set up in the Federal Institute for Occupational Safety and Health (BAuA).
Current changes – sunset dates
The term "sunset date" refers to the final date after which materials that were added to Annex XIV may no longer be used without authorisation. Since 2015, the use of the following substances is subject to restrictions:
- Benzyl butyl phthalate (BBP),
- Bis(2-ethylhexyl)phthalate (also Diethylhexylphthalate, DEHP),
- Dibutylphthalate (DBP),
- Diisobutylphthalate (DIBP),
- Diarsenic pentaoxide or Arsenic(V)-oxide (As2O5),
- Diarsenic trioxide or Arsenic(III)-oxide (As2O3),
- Lead chromate molybdate sulfate red (C.I. Pigment Red 104),
- Lead(II)-chromate, PbCrO4 (C.I. Pigment Yellow 34),
- 2,4-Dinitrotoluene (2,4-DNT),
- Hexabromocyclododecane (HBCDD) and
- Tris(2-chloroethyl)phosphate (TCEP).
As of 21 April 2016, Trichloroethene had been added to the list of restricted use substances.
From next year onwards, companies that wish to continue using the following substances in their products must apply for authorisation:
- Diarsenic pentaoxide or Arsenic(V)-oxide (As3O4),
- Bis(2-methoxyethyl)ether (Diglyme),
- Oligomeric reaction product of formaldehyde with aniline (techn. MDA),
- Acids obtained from chromiumtrioxide (Chromium(VI)-oxide) and its oligomers (including chromic acid and dichromic acid),
- Chromiumtrioxide (CrO3),
- Potassium chromate,
- Potassium dichromate,
- Potassium chromate,
- Potassium dichromate(VI),
- 1,2-Dichloroethane (Ethylenedichloride, EDC) and
- 4,4′-Methylene-bis(2-chloroaniline) (MOCA)
From 2017 onwards, these substances will also be listed in the List of materials requiring authorisation.
Do you need any help or more information for understanding and dealing with REACH issues? Please feel free to contact us. You will find trainings on issues related to REACH in our seminar and webinar schedule for 2016 (as a PDF file under the "Training" column).
Our webinars on this topic:
In the webinar "REACH Annex XIV – Sunset Date", you will learn how to deal with bans on substances and will prepare yourself for it. In exercises assigned to you, you will find solutions for the identification and substitution of basic substances and will put these solutions into practice. In this way, you can declare materials used in your products in conformity with existing laws.
The webinar "IMDS Analysis Functions" points out to you the functions of the IMDS system with which you can analyse material data sheets in respect of materials used, basic substances used and their classifications. You will be able to prepare and interpret proofs of use of substances.