What is REACH?
REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals. It came into force on 1st June 2007 and replaced a number of European Directives and Regulations with a single system.
REACH has several aims
• To provide a high level of protection of human health and the environment from the use of chemicals.
• To make the people who place chemicals on the market (manufacturersand importers responsible for
understanding and managing the risks associated with their use.)
• To allow the free movement of substances on the EU market.
• To enhance innovation in and the competitiveness of the EU chemicals industry.
• To promote the use of alternative methods for the assessment of the hazardous properties of
substances e.g. quantitative structure-activity relationships (QSAR) and read across.
It is estimated that there are around 30,000 substances on the European Market in quantities of 1 tonne or more per year. Registering all of these at once would be a huge task for both industry and regulators. To overcome this, the registration of those substances already being manufactured or supplied is to take place in three phases. These phases are spread over 11 years:
• Details of this timeline
To benefit from these phased-in deadlines manufacturers or importers need to pre-register their substances from 1st June to 1st December 2008.
With the help of pre-registration manufacturers and importers gets benefit to evaluate their business and start Final Registration process before below deadline
Final Registration Deadline
• 1 MT – 10 MT/ Per Year – May 2018
• 10 MT – 100 MT/Per Year – May 2018
• 100 MT – 1000 MT/Per year – May 2018
• 1000+ MT – November 2010
For a substance to be eligible for late pre-registration the substance must be what is known as a ‘phase-in’ substance. This means that:
• The substance is listed on EINECS, i.e. those on the EU market before 1981
• The substance was manufactured in the Community, or in countries acceding to the EU on the 1st January 1995 or on 1st May 2004, but not placed on the market by the manufacturer, at least once in the 15 years before entry into force of this Regulation, provided the manufacturer has documentary evidence of this. (Basically, these are substances that have been made in the EU but not placed on the market there. They will generally be site limited or export only substances. Evidence of this should be available if challenged)
• The substance is a so called ‘no longer polymer’
In addition, it must be the first time that the substance has been imported or manufactured in quantities of one tonne per year or more by the legal entity in question. The pre-registration needs to be done within 6 months of the first import/manufacture and no later than 12 months prior to the appropriate registration deadline. This that any further pre-registrations need to be submitted by 31 may 2017 and can only cover supply at less that 100 tonnes per year.
Pre-registration will mean informing the European Chemicals Agency (ECHA) of:
• The name of the substance as specified in section 2 of REACH Annex VI, this includes CAS, EINECS or other identification codes
• Name and address of the contact person or representative
• Envisaged deadline for the registration and the tonnage band
• Identifier information of any structurally similar chemical which you may wish to rely on to provide useful evidence on hazards as part of your registration package
Registration is a requirement on industry (manufacturers/importers) to collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above 1 tonne per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki. Further information on registration can be found on the ECHA website .
For further information and procedure, please contact (email id)
Registration is the process in which manufacturers, importers and Only Representatives (OR) collate information on the substances they manufacture or import and use that information to assess the potential hazards. This information is added to a registration dossier that is sent to the European Chemicals Agency (ECHA). With this information on the properties of the substance, and by working with others in the supply chain, the manufacturer, importer or OR can assess any risks to human health and/or the environment and develop appropriate risk management measures for the various uses of the substance.
Registration involves a number of steps; looking for existing data, sharing data where it exists, creation of the electronic registration dossier and sending that dossier to ECHA. These processes are explained below.
Reach Only Representative
REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than 1t/year to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration; however, non-EU companies may submit registration by appointing an EU-based Only Representative to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.
Pharmegic Healthcare Limited provides Pharma & Chemical regulatory compliance and product safety solutions globally. Pharmegic Healthcare Limited has its headquarter in Ireland and offices in India & China.