Asian Centre for European Environmental Policy Research (ACEEPR)

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Environment and EU Policy Regulations Newsletter
March 2007 / Issue 2

  In this issue
 
   
 
  Biannual Newsletter on Environment and EU Policy Regulations    Volume 1, Issue No. 2    ISSN No.  
 
 
 

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Introduction
The European Commission proposed a new EU regulatory framework for the Registration, Evaluation and Authorization of Chemicals (REACH) on 29 October 2003.The aim was to improve the protection of human health and the environment through the better and earlier identification of the properties of chemical substances.

The REACH proposal places greater responsibility on the industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their substances, which will help them manage the substances safely and to register the information in a central database. A European Chemicals Agency (Agency) will act as the central point in the REACH system. It will run the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.

From 1st June’ 2007, every European chemical producer, manufacturer or an importer will have to register the chemicals he produces or uses as an approved substance. The approval process will take place in phases over the next ten years.Thus REACH is applicable to importers and manufacturer of the products within Europe.

  
 
 
           
       

What is REACH?
Reach consists of the following elements


 
 
Registration

This requires industry to obtain relevant information on their substances and to use that data to manage them safely.
There is a general obligation to register substances manufactured or imported in quantities starting at 1 tonne. Failure to register means that the substance cannot be manufactured or imported.

Registration requires submission of a technical dossier containing information on the substance and information on risk management measures, as well as - starting at 10 tonnes -the chemical safety report that documents the choice of these measures. For the registration of substances in articles, a special regime applies; certain substances incorporated into articles have to be registered when the substance in question has hazardous properties and is intended to be released from the article. Polymers are exempted from the requirement to register.

  



 
Evaluation

This provides confidence that industry is meeting its bligations and prevents unnecessary testing.

There are two types of evaluation

  
 
  • Dossier evaluation, which is twofold again: One aim is to prevent unnecessary animal testing. Therefore the regulation requires authorities to examine proposals for testing in order to check the quality before a test is performed and to prevent the same animal test to be performed repeatedly; Furthermore, the regulation gives authorities the task to check compliance of registration dossiers with the requirements of the registration title
  • Substance evaluation: provides a mechanism for an authority to require industry to obtain and submit more information in case of suspicion of a risk to human health or the environment.
  
 
To promote a consistent approach, the Agency will develop guidance on prioritization of substances for evaluation.
  

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Authorization

Risks associated with uses of substances with properties of very high concern will be reviewed and, if they are adequately controlled, or if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies, then the uses will be granted an authorization.The substances selected for the authorization system will be those having hazardous properties of such high concern that it is essential to regulate them through a mechanism that ensures that the risks related to their use are assessed, weighed and then decided upon by the Community prior to actual use. Substances of very high concern are defined as: substances that are category 1 and 2 carcinogens or mutagens; substances that are toxic to the reproductive system of category 1 and 2; substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative; and substances such as endocrine disrupters which are demonstrated to be of equivalent concern.

The authorization provisions require those using or making available substances with properties of very high concern to apply for an authorization of each use within deadlines set by the Commission. Deadlines shall be set for a number of substances at a time. The burden of proof is placed on the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks. Downstream users may use a substance for an authorized use provided they obtain the substance from a company for whom an authorization has been granted and that they keep within the conditions of that authorization. Such downstream users shall have to inform the Agency of this fact so that the authorities are fully aware of how and where substances of very high concern are being used.
  
 
Restriction

The Restrictions procedure provides a safety net to manage risks that have not been adequately addressed by another part of the Reach system.
The restrictions provisions act as a safety net for the whole Reach system because any substance on its own, in a preparation or in an article may be subject to Community-wide restrictions if a risk needs to be addressed.Proposals for restrictions shall be prepared by Member States or the European Commission in form of a structured Dossier. This Dossier is required to demonstrate that there is a risk to human health or the environment that needs to be addressed at Community level and to explore the options for managing that risk.
The restrictions provisions are the result of a balance of the need to ensure that action is taken where required as rapidly as possible, to provide a sound scientific basis for any restriction and to enable all interested parties to participate in the procedure. The Chemicals Agency will manage the technical, scientific and administrative aspects of the Reach system at Community level, aiming to ensure that the Reach system functions well and has credibility with all stakeholders.
Innovation of safer substances will be encouraged under REACH through reporting exemptions for chemicals used in research and development (as opposed to those that enter mass production) and lower registration costs for new, safe substances. The directive will require industry to consider substitute substances in certain cases, which will help decision-makers make authorizations and restrictions. Industry will be responsible for assessing the safety of identified uses before production and marketing. Authorities will be able to focus on issues of serious concern.
  
   
 
 


REACH Exemptions

  • Polymers are for the time being exempted from registration and evaluation
  • Non-isolated intermediates
  • Substances used in the interests of defense.
  • Waste
  • Substances in food and medicinal products
  • Minerals, ores and or concentrates as long as they are not chemically modified
  • Water, oxygen, noble gases and cellulose pulp
  		  
 
  REACH Time Lines


 
 
June 2007
Entry into force of REACH
June 2008
European Chemicals Agency becomes operational
June 2008 to November 2008
Pre-registration of  phase-in substances
November 2010
Registration deadline substances in quantities of 1000 tonnes and above, CMR category 1 and 2 and substances classified as very toxic to aquatic organisms 
June 2013
Registration deadline for substances in quantities of 100 tonnes and more
June 2018
Registration deadline for substances in quantities of 1 tonne and more
 
 
Indian/Asian industries implicated by REACH

  
 

The following exporting industries will be mainly implicated by REACH

  • Organic chemical industry
  • Inorganic chemical industry
  • Industries manufacturing Specialty chemicals
  • Pharmaceutical industry
  • Pesticides
  • Textile & Dyeing industr
  
 
 


Compliance Road Map

Preparation for compliance by Indian suppliers will involve the following

  
 
  • Identify all products (substances, preparations, semi-finished goods, articles) imported into the European Economic Area and therefore potentially falling under REACH
  • Break down products to substance level (under REACH, substances are regulated even if contained in preparations, in this case on the textile and garments) and identify their CAS (Chemical Abstracts Service) numbers
  • Collect all available data on these substances
  • Identify substances of highest concern (Persistent, bio-accumulative, carcinogenic and toxic)
  • Identify data gaps
  • Seek help from external service providers to help them take steps towards REACH compliance
  • Formation of a consortia / cluster of a few SME’s to make collective efforts to prepare for REACH
  • Need to track the developments on REACH
  • Participate at the consultative stages of these legislations (Branch Organizations can play an important role.)
  • Train Internal staff – on the specific regulations
  • Develop compliance strategy
  • Compliance reporting - to stakeholders
  
 
REACH Events

  
 

21 March 2007 - REACH Implementation Workshop, Durham, UK

This REACHReady workshop, run in partnership with Nepic will help and advise chemical manufacturers and the supply chain how to start to prepare for REACH.

 17-18 April 2007 – RAPRA REACH 2007 Conference, Brussels

Rapra Technology's first international conference on REACH. The conference will look at streamlining compliance costs.

1-3 May 2007 – Sustainabilitylive, NEC,Birmingham, UK

Sustainabilitylive! is the UK’s premier multi-disciplinary event for environmental professionals.  This seminar will look at the impacts of REACH on all business
  







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