Introduction and objectives

REACH: Registration, Evaluation and Authorization of Chemicals

REACH comes from the publication in 2001 of a White Paper of the European Commission. This white paper’s main objective is to better manage the environmental and health risks that may result from the production and use of chemicals.

December 18, 2006, after six years of discussion, the Council of the European Union has unanimously adopted the REACH project. The regulation came into force officially on 1^st June 2007. This enactment modernizes the European legislation on chemicals, and establishes a single integrated system for Registration, Evaluation and Authorisation of Chemicals and Restriction of Chemicals in the European Union.

Here are the objectives of REACH on its entry into force on 1^st June 2007:

• Increase the protection of human health and the environment
  • By improving knowledge of hazards of chemicals and risks associated with their use ;
  • By ensuring better risk management ;
• Improve transparency between all actors ;
• Maintain and enhance the competitiveness of the European chemical industry, encouraging innovation.

Priority actions

Priority actions for all producers, importers and users of chemicals in Europe are:

Before december 2008	- Communicate with the concerned suppliers - Make sure of intentions of pre-registration and registration of substances
Upon publication of the list	- Investigate wether substances of concern which are candidates for authorization are used as such in your articles - Contact relevant suppliers to know about their intentions and anticipate the impact - Provide your customers with information for use of articles containing candidate substances
From january 2009	- Check the pre-registration of substances used and boost communication - Interact with suppliers about taken into account your use
November 2010 May 2013 May 2018	- Check the registration of substances used as scheduled - Check the consideration of your use in the updated safety data sheets (MSDS) and apply appropriate risk management recommendations

REACH general process

Registration’s dates of all new and existing chemicals by tonnage:

• [> 1000t]: before 1 December 2010 ;
• [> 100t; <1000t]: before June 2013 ;
• [>1t ;<100t]: before June 2018.

• Pre-registration: before November 30, 2008.

Pre-registration Deadline:

• Any manufacturer or importer of substances that did not meet that first deadline will no longer manufacture or import of substances in quantities above one tonne per year, unless it shall immediately submit a full registration report.
• Substance users can no longer continue to use them, if they were not pre-registered or registered by an upstream actor in the supply chain.

How to know if a substance is pre-registered?

• Check with suppliers / distributors who ask for information to manufacturers
• http://echa.europa.eu/home_en.asp

What is reports assessment?

• Report conformity control: the agency check the quality of reports;
• Examination of testing proposals: the Agency or the European Commission decides if testing is necessary;
• Substance assessment: States shall carry out scientific assessment when substances are suspected to be harmful to humans and the Environment.

At the end of the evaluation process of a substance, REACH regulation may lead to two consequences for this substance:

• The inclusion of the substance in the candidate list for authorization: This means that the substance can not be placed on the market or used by a company if that company did not obtain prior authorization from the European commission.

Link to the website of ECHA on the candidate list for authorization:
http://echa.europa.eu/fr/regulations/reach/authorisation/the-candidate-list

Be careful: the addition of a substance in the candidate list for authorization requires chemical suppliers disclosure obligations to their clients about the concerned substances.

• The implementation of austerity measures aimed at limiting or prohibiting: the manufacture, marketing or use of this substance.

Link to the website of ECHA on proposed restrictions:
http://echa.europa.eu/fr/web/guest/addressing-chemicals-of-concern/restriction
Link to the national regulatory Helpdesk support – French:
http://www.ineris.fr/reach-info/

Regulation exemptions

This list is periodically updated.

• REACH is not applicable to:
  • radioactive substances[1]
  • substances subject to customs control, temporary storage, in a free zone or free warehouse for re-exportation or in transit ;
  • transportation of hazardous substances on their own or in preparations (all modes) ;
  • wastes which are not considered as substances or preparations ;
  • polymers which are not subject to the procedure of evaluation and authorization for the moment ;
  • the establishment of exemptions by Member States is also possible if necessary in the interests of defence.

References

– European chemical agency website: http://echa.europa.eu/en/web/guest/home
– CEDEF. REACH: a new control system for chemicals http://www.minefe.gouv.fr/directions_services/cedef/synthese/reach/textes.htm – french
РSamira Abdesslam, CETIM (Centre Technique des Industries M̩caniques). REACH, its general principles, where is in its implementation? what should you do absolutely careful, today ?. March 2011 Рfrench

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[1] See Directive 96/29/Euratom of Council of 13 may 1996