REACh

The REACh Regulation came into force on June 1, 2007. REACh stands for Registration, Evaluation, Authorisation of Chemicals and is based on the principle of independent responsibility within the industry. The regulation therefore places responsibility on manufacturers and importers to the same extent as industrial and commercial users/processors.

Employing the principle of reversing the burden of proof, REACh shifts the responsibility for examining chemical safety to these groups. They must demonstrate convincingly that their products are safe to handle and do not unnecessarily harm the health of either processors or consumers or damage the environment. This is no longer a task of the national authorities.

Evaluation and use of chemicals in the EU is to largely governed by the REACh regulation (Regulation 1907/2006/EC and amendments) which came into effect on 1 June 2007. REACh unifies a number of co-existing legal documents in EU chemical legislation and supplements them with new aspects. The aim of the regulation is to improve the information available about chemicals manufactured in the European community and imported into the EU. It is also intended to reduce the risks associated with the use of chemicals.

Because we prioritized our efforts to meet the requirements of REACh in full, we launched into our preparations early. We are happy to support both our customers and suppliers in questions of meeting the various requirements. Let's work together to fulfill our responsibilities as businesses in the chemical sector, with pride and commitment.

All substances manufactured or imported in quantities of more than 1 ton per annum must be registered with the new European Chemicals Agency (EChA) in Helsinki - which in effect means that basic data on identity, impurities, classification, waste disposal and handling have to submitted in the form of a registration dossier. It is not the products that are registered but the individual substances - even if they are a constituent of a preparation or of a product. On the principle of "no data, no market," only previously registered chemicals can be placed on the EU market. Substances that have not been registered thus become illegal.

Another special feature of REACh is the extension of communication within the supply chain. This is because one of the basic ideas of REACh is to establish comprehensive risk management for the entire life cycle of a given chemical. Consequently, the entire sales chain is incorporated into the REACh process. The regulation not only affects the manufacturers and importers of chemical substances but also companies that employ chemicals in the widest sense, the so-called downstream users.

Typical downstream users are:

  • Formulators who manufacture preparations from different substances (for example: adhesives, paints, construction chemicals)
  • Companies that employ substances or preparations in order to manufacture products (for example: the plastics and rubber industry, pharmaceuticals, automotive industry, engineering and plant construction, electroplating and surface coating plants)
  • Companies that provide services using substances or preparations (for example: trades such as painter decorators or cleaning companies)
  • Reimporters of registered substances

Obligations of downstream users

Downstream users also have tasks and duties.They must provide their upstream manufacturer or importer with information on the precise use so that it can take account of this application in its information on exposure in the technical dossier and, where applicable, in its exposure scenarios and thus recommend suitable risk management measures. The application then becomes an "identified use." In this case the downstream user is not required to conduct any independent registration but must apply the risk management measures recommended by the manufacturer/importer.

If the manufacturer/importer does not identify the individual application by including it in its Safety Data Sheet - perhaps because it views the risk from this application as too great - or does not wish to notify the downstream user of the application in order to maintain company secrecy, the downstream user may have to submit an independent use registration, detailing the hazard potential for humans and the environment together with safety precautions.

Responsibilities under REACh

The first specific REACh process is pre-registration of what are called phase-in substances from June 1 to December 1, 2008. Registration of high-volume, environmentally harmful and particularly hazardous substances (CMRs) has to take place within the first 3.5 years after the law has come into force; registration periods from 3.5 to 11 years have been defined for additional substances.

REACh deadlines

1 June 2007REACh comes into force
1 June 2008Start of pre-registration
1 December 2008End of pre-registration
1 January 2009Publication of the pre-registered substances,
start of registration
1 June 2009EChA proposes substances that have to undergo an authorization procedure
1 December 2010End of registration period for
substances ≥ 1.000 t/a
CMRs ≥ 1 t/a
Environmentally hazardous substances ≥ 100 t/a
1 June 2013End of the registration period for substances ≥ 100 t/a
1 June 2018End of the registration period for substances ≥ 1 t/a
reach-deadlines.pdf

Expressed in simple terms, phase-in substances is the official name for "existing substances." As defined in the REACh regulations, phase-in substances must meet at least one of the following criteria:

  • The substance is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). EINECS is the directory of substances that were on the market before 1981. It contains more than 100,000 existing substances
  • The substance was manufactured in the EU, but not placed on the market by the manufacturer or importer in the 15 years prior to the entry into force of REACh (for example. substances used within a company)
  • The substance was classified as a polymer until the early 1990s (entry into force of the 7th amending directive 67/548/EEC) and was counted as registered, but does not satisfy the definition of a polymer according to the REACh regulations. Certain emulsifiers and prepolymers, for example, fall into this category. These substances are also termed "No-Longer Polymers" (NLP) and are contained in the NLP list.

Substances that fulfill none of the stated criteria are either "notified substances" that are considered registered as per Article 24 or "non phase-in substances." Transition rules apply to these substances so as not to obstruct the continued marketing of the large number of these phase-in substances that are already on the market. During transition periods of three and a half to eleven years, these substances may continue to be manufactured and placed on the market on the condition that they were preregistered with the EChA between 1 June 2008 and 1 December 2008. After expiry of the transition deadlines, phase-in substances may also only be manufactured or placed on the market if they are registered.

German-language links

http://reach-hamburg.de/
The REACh-Hamburg network is a group of opinion-makers and cooperation partners from business and local government agencies who came together to provide support for companies in the Hamburg economic area to implement REACh. Lehmann&Voss&Co. is part of this group.

http://www.reach-helpdesk.de/
Help desk of the Federal Institute for Occupational Safety and Health. This national information site for manufacturers, importers and users of chemical substances provides information and guidance on the implementation of REACh and offers support on issues related to the registration, evaluation and authorization of chemical substances.

http://echa.europa.eu/de/
Website of the European Chemicals Agency (ECHA) with information in 22 languages

http://www.reach-info.de/
Information page of the German Environment Agency

https://www.vci.de/Themen/Chemikaliensicherheit/REACh/Seiten/Listenseite.aspx
REACH section of the German Association of the Chemical Industry (VCI)

http://www.bdi.eu/Stoffpolitik.htm
The umbrella organization for German industry (BDI) on the subject of REACh

English-language links

http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
DG Enterprise and Industry of the EU Commission

http://www.cefic.org/Regulatory-Framework/Governmental-Initiatives-and-Regulations1/reach/
REACh pages of the European Chemical Industry Council (CEFIC)

Thanks to our intensive and long-standing involvement with REACH, we can provide detailed answers for questions such as the following: Will the product remain available? Will all ingredients be preregistered and registered? Which exposure scenarios / applications are covered with a registration? Has contact already been initiated with other market participants or consortia? Are extended safety data sheets available? What preparations/activities are essential for implementing REACH?

Coordination and control of the implementation of REACH is managed in the service group 'Safety and Environmental Protection' of Lehmann&Voss&Co. by
Dr Heiko Thoms,
Phone: +49 (0) 40/44 197-454,
E-mail: 
Heiko.Thoms(at)lehvoss.de

The Legal Department of Lehmann&Voss&Co. is also involved in the implementation.
Hubertus Richert,
Phone: +49 (0) 40/44 197-260,
E-mail: hubertus.richert(at)lehvoss.de is responsible for this area.

Also at Auer-Remy GmbH there is a knowledgeable fixed contact person for REACH who is available at all times for Information:

Product Group/Contact PersonPhoneEmail

Auer-Remy GmbH

Sebastian Winkelmann +49 (0) 40 44 197 181 Sebastian.Winkelmann(at)lehvoss.de
your-contacts-for-reach.pdf

Roughly nine years passed from the first attempts to implement REACh until it came into effect. LuV was very intensively involved with this issue right from the start and for us it was about giving our customers certainty as early as possible that our products will continue to be available.

This also included explaining to our non-European suppliers whether, and if so, which substances they (or a representative within the EU) would have to have registered or in which cases we would have to take this on. This is because we are affected by REACh in many ways through our business model – Distribution, Production and Trade – and we have different roles for different materials which results in different obligations.

We are actively involved with the implementation of the REACh requirements and have already acquired important experience.

LuV

  • has preregistered approx. 800 substances
  • successfully submitted three registrations in 2010/2011
  • successfully submitted a further 5 registrations in 2013
  • plans several further registrations between now and 2018; a prioritization process has been established for this purpose
  • uses 'only representative' regulationsto be able to omit some of the mandatory regulations
  • uses internal and external networks for regular exchanges of experience (e.g., VCI North Regional Association, REACh Hamburg Network (http://www.reach-hamburg.de/)
  • has developed process instructions to ensure that the requirements are met and that products remain marketable
  • uses modern software systems to support compliance with REACh

Please contact us if you have questions or would like provide information about your experiences in this area.