REACH

The European Union (EU) enacted its regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals, or REACH, on 1 June 2007 with a phased programme of implementation over 11 years.

Described as 'the most ambitious chemicals legislation in the world', REACH is having significant and potentially extensive implications for all businesses involved in the production, and directly export or are part of the supply chain that export to the EU.

  • After more than 3 years of discussion, the REACH Regulation (1907/2006) was adopted on 18 December 2006. REACH replaces a raft of existing EU legislation, creating a single system for all chemical substances, with implications for producers and users alike.

  • REACH requires manufacturers and importers to register chemicals manufactured or marketed in Europe in quantities higher than 1 tonne per year with the new European Chemicals Agency (ECHA) in Helsinki and, in doing so, to adequately demonstrate their safe use through a comprehensive programme of data collection, testing and assessment. Failure to register means the substance cannot be manufactured in or imported to the EU. For existing substances, there is an option to pre-register and take advantage of a phase-in programme for registration, which prioritises substances of higher volume and certain substances that have irreversible health effects or may cause long-term adverse impacts to the aquatic environment. New substances need to be registered before they are placed on the market, commencing 1 June 2008. Substances of very high concern will also be subject to further rules under the authorisation regime, and their use may be phased out or subjected to further controls or restriction accordingly.

  • For the first time, downstream users, including formulators and manufacturers of products containing chemicals in quantities higher than 1 tonne per year, also have direct legal obligations under REACH, as well as various potentially far-reaching commercial implications to consider.

  • The European Commission has estimated that approximately 30,000 substances are currently marketed in the EU in volumes above 1 tonne per annum. With the Regulation itself extending to over 700 pages of text and supporting guidance being more expansive still, the scope of REACH is such that it presents important challenges for large and smaller organisations alike, and applies to many international and non-European, as well as European, organisations. For many companies, REACH drives change through all aspects of their business.

 

REACH Regulation and the Only Representative

REACH regulation requires European Union (EU)-based manufacturers and importers of chemicals to register individual substances with the European Chemicals Agency (ECHA) before they can continue to manufacture or import those products in the EU. The registration deadline is extended for those companies that pre-register their substances before 1 December 2008. EU manufacturers or importers that do not pre-register or register will not be allowed to continue to manufacture or import substances.

Only Representative - ‘OR’

The Only Representative plays a critical role for non-EU manufacturers of chemicals. Non-EU  manufacturers that export chemical substances to the EU cannot pre-register or register their substances directly. Article 8 of REACH (Regulation (EC) No 1907/2006) specifies that manufacturers of chemicals substances outside the EU may appoint an Only Representative to fulfill REACH registration obligations as follows:

  • •  A natural or legal person established outside the European Community (EC) who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the EC may by mutual agreement appoint a natural or legal person established in the EC to fulfill, as his only representative, the obligations on importers under this Title.

  • •  The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the Safety Data Sheet (SDS) referred to in Article 31.

  • •  If a representative is appointed in accordance with paragraphs 1 and 2, the non-EC manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

 

Advantages of Appointing Only Representative (OR)

Appointing an Only Representative provides many advantages to the manufacturer:
The manufacturer does not need to operate in the EU. The manufacturer’s customers (i.e., importers) are not obliged to register the individual substances. For the purposes of REACH, your importers become downstream users and will face fewer obligations. The manufacturer has direct control over the registration process of its substances. The manufacturer may expand its customer base without restriction. Confidential data are communicated exclusively to an impartial partner (i.e., the Only Representative) rather than the manufacturer’s supply chain customers.

 

PCC UK Ltd- The ‘OR’ of  NPC/PCC

As indicated in above, in accordance with article 8 of REACH Regulation, non-EU manufacturers cannot register their substances directly, therefore in an agreement, National Petrochemical Company (NPC) and Petrochemical Commercial Company (PCC) has jointly introduced PCC (UK) Ltd as the Only Representative (OR) to fulfil the REACH Regulation obligations for Registration of Substances and Mixtures with a phased programme of implementation on behalf of all petrochemical manufacturers in Iran. The Expiry date for full registration of those substances with importation weight of 1000 and greater tpa (tonnes per annum) was 30 November 2010 (first phase-in deadline). For the importation substances and mixtures of 100 and greater tpa (tonnes per annum) the expiry date is 30 June 2013 (second phase-in deadline) and for 1 and greater tpa the registration expiry date is 30 June 2018 (third phase-in deadline).

PCC UK has Pre-registered all its substances and mixtures and also Registered all substances in its first priority list for which the importation tonnage was said to be above 1000 tpa, and continues to register the remaining substances within the due dates.

 

REACH Deadlines

Transitional provisions apply for all substances that are currently on the market. Different deadlines are set for registration of “phase-in substances”

 Date

 Activities

 1 June 2007

   • REACH enters into force

 1 June 2008

  • European Chemicals Agency becomes operational
  • Pre-registration period for existing stances (also known as phase in substances)
  • Registration of new substances (also know as non-phase in substances)

 1 December 2008

  • Pre-registration period for phase in substances ends
  • Assignment of registration numbers for “phase in substances”

 1 January 2009

  • Pre-Registration list published

 30 November 2010

  • Classification/labelling submission deadline

  Registration deadline for :

  • Substances in quantities of 1,000 tonnes and above
  • Carcinogens, mutagens and substances toxic to reproduction (CMR) category 1      and 2, above 1 tonne per year
  • Substances classified as very toxic aquatic organisms , above 100 tonnes per year

 1 June 2011

  • Submission of notification of substances of very high concern (SVHC) in articles

 31 May 2013

  • Registration deadline for substances (above 100 tonnes per year that are exported     to the EU)

 31 May 2018

  • Registration deadline for substances (above 1 tonne per year that are exported to     the EU)

 

Evaluation of Substances

The European Agency and the Member States Competent Authorities will carry out different types of evaluations to determine the need for further information on the registered substance.
There are three types of evaluation, covering three different objectives:

Dossier evaluation: The European Agency will perform the following checks of the registration dossiers:
Compliance check: The Agency may select any registration dossier to check whether the appropriate information is available and has been adequately reported. The registrant may be asked to submit further information if necessary.
Checking of testing proposals: for chemicals manufactured or imported in a quantity of 100 tonnes or more, no testing shall be conducted for the information specified in Annexes IX and X of the REACH Regulation. Instead a testing proposal must be submitted in the registration dossier. The Agency shall then evaluate whether the testing proposal is adequate before such a test is performed. The objective of this procedure is to prevent unnecessary animal testing, i.e. the repetition of existing tests, and poor quality tests.

Substance evaluation: When the Agency or a Member State Competent Authority has an indication that a substance may pose a risk to human health or the environment, the Agency will include that substance on a list for “substance evaluation”. For each substance on this list, one Member State shall evaluate in more detail whether further information is needed and in that case the registrant(s) will be requested to provide such information.

 

Authorisation

Substances of Very High Concern (SVHC) will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an authorisation.

What Substances are referred to as SVHC?

SVHC include substances which are:

  • Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2,
  • Persistent, Bio-accumulative and Toxic (PBT) or very Persistent and very Bio-accumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
  • identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters

 

Why and how do these substances need to be regulated?

These substances have hazardous properties of very high concern. It is essential to regulate them because the effects they can have on humans and the environment are very serious and often irreversible. There is no tonnage threshold for a substance to be subject to authorisation.

The authorisation mechanism consists in an in-depth assessment. Its outcome is then thoroughly discussed before appropriate decisions are taken.

 

How will the authorisation process look like in practice?

The authorisation process consists of four steps. Industry has obligations in the third step. However, all interested parties have the opportunity to provide input in steps 1 and 2.

 

Step 1: Identification of substances of very high concern (by authorities)
Step 2: Prioritisation process (by authorities)
Step 3: Applications for authorisation (by industry)
Step 4: Granting of authorisations (by the European Commission)


Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. The “adequate control route” does not apply for substances for which it is not possible to determine thresholds and substances with PBT or vPvB properties.
If the risk is not adequately controlled, an authorisation may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.

Restriction of Substances

Restrictions will be imposed on substances that cause unacceptable risks to health or the environment. Annex XVII of the REACH Regulation contains the list of all restricted substances and the uses which are restricted.

Existing restrictions set out in the Marketing and Use Directive (76/769/EEC), e.g. the ban on asbestos and restrictions on the uses of certain azo-dyes, have been carried over to REACH in Annex XVII.

 

Types of Restrictions

Restriction may be imposed on the manufacture, import and use of:

  • • The substance itself.
  • • Preparations which use the substance.
  • • Products containing the substance.

 

Restriction may be in the form of:

  • • Limits on the concentration/amount of substances.
  • • Limits on certain or all uses of the substances.
  • • Outright bans on the substances.
• Check the ECHA website to find out which substances have been considered for restriction and the type of   restriction.

 

Classification & Labelling

The pre-existing EU chemicals legislation already requires industry to classify and label dangerous substances and preparations according to standard criteria.

REACH builds on this existing legislation but does not contain the criteria or the obligations relating to classification and labelling. Under REACH, businesses must submit classification/labelling information in accordance to the new EU regulation on classification, labelling and packaging of chemical substances and mixtures (CLP) to ECHA for the following substances:

  1.               1. Substances that must be registered under REACH.
              2. Substances that are classified as dangerous even if they are or placed on the markets (e.g.                   imported) or manufactured in quantities below one tonne. This includes dangerous substances                  under pre-REACH Directive 67/548/EEC.

 

References:


REACH – Annex XVII
http://ec.europa.eu/enterprise/sectors/chemicals/files/markrestr/annex_xvii_301206_en.pdf