GAP Analysis provides technical support to businesses in compliance with new REACH and CLP regulations.

The REACH Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, is the new European Community law on chemicals and their safe use that entered into force on 1 June 2007.

According to REACH , all companies that manufacture or import chemical substances into the European Union in quantities of one tonne or more per year have to register these substances to the European Chemicals Agency (ECHA).

REACH does not apply to radioactive substances, the substances under customs supervision, non-isolated intermediates, the carriage of dangerous substances by rail, road, inland waterway sea or air, waste and member states exceptions for defense purposes. The Regulation comprises the following stages of implementation:

  • Pre-registration: Deadline December 1, 2008.
  • Registration: Three major deadlines for registration of chemicals have been set. In general these are determined by tonnage manufactured or imported, with 1000 tonnes/annum being required to be registered by 1 December 2010, 100 tonnes/annum by 1 June 2013 and 1 tonne/annum by 1 June 2018 for specific substances categories.
  • Evaluation: ECHA is responsible to examine the registration of chemicals and the information included in the substances registration technical dossiers. The evaluation may lead to further regulation of the substances or even the restriction of them. REACH Restrictions (Annex XVII): The restrictions procedure is a safety net for substances posing an unacceptable risk to human health or the environment arising from its manufacture, use or placing on the market, which need to be addressed on a Community wide basis.
  • Authorization of Chemicals: Authorization is one of the REACH processes for managing the risks of hazardous substances and especially substances of very high concern. Substances that are subject to authorization (substances included in Annex XIV) shall not be placed on the market , unless a company (and their registered users) has been authorized to do so.

The CLP Regulation

The CLP Regulation EC No 1272/2008 on Classification, Labeling and Packaging of substances and mixturesis the European Union law which aligns the European Union system of classification, labeling and packaging of substances and mixtures to the Globally Harmonized System (GHS). The CLP Regulation entered into force in 20 January 2009.

The CLP Regulation will, after a transitional period, replace the current rules on classification, labeling and packaging of substances (Directive 67/548/EEC) and mixtures (Directive 1999/45/EC). The date from which substances classification and labeling must be consistent with the new rules is 1 December 2010 and for mixtures 1 June 2015.

The Regulation does not apply to radioactive substances and mixtures under customs supervision, substances for scientific research and development (not marketed), non-isolated intermediates, wastes, medicinal products, veterinary medicinal products , cosmetics, medical devices , food or feeding stuffs The Organizations that are responsible for the implementation of REACH & CLP Regulations are:

General Chemical State Laboratory (Directorate of Environment) European Chemicals Agency (ECHAServices provided by GAP Analysis include:.

  • Determination of company obligations according to REACH and CLP regulations and national legislation (e.g. schedule preparation and submission of dossiers, international representation of company, data collection, analysis and determination of physicochemical experiments for the documentation of the registration technical dossiers , requirements of suppliers and customers within the EU, etc.)
  • Classification and labeling of chemicals in accordance with REACH and CLP requirements
  • Development and registration of technical dossiers using IUCLID software
  • Development of internal audit system for controlling all chemical substances entering the business
  • Development of Material Safety Data Sheets (MSDS)
  • Determination of Strictly Controlled Conditions – (SCC) for processing, storage, loading, unloading and transport of intermediate products
  • Continuous monitoring of the registration dossiers procedure and relevant communication with authorities and working groups
  • Personnel training related to REACH and CLP regulations for the classification of substances, the use and development of MSDS etc.