REACH Explained contains simple and easy to understand elucidation of the complex legal REACH regulation for the benefit of the Indian industry. This shall help the industry to identify applicability of REACH to their export item and also provide them with a road map on what actions they should take for meeting their obligations within REACH. This section contains qualified information on only those issues that are relevant to the Indian industries from the point of view of the actions to be taken to ensure REACH compliance.
Why and What’s covered within REACH
The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) chemical policy applies to all chemicals and chemical containing substances, preparations or articles exported to the European Union (EU) in quantities exceeding one tonne per annum.
The REACH chemical policy is an elaborate piece of legislation that has been implemented by integrating over 40 different chemical legislations. This will ensure that there is only one chemical policy that the manufacturers of chemicals will have to adhere to. The other important reason for REACH coming into force is that it will result in the generation of vital data on the safety of the chemicals, an objective that could not be achieved with other chemical legislations. It is important to mention here that generation of new safety data shall involve animal testing only as the last resort within REACH.
It is based on the principle that it is the duty of manufacturers, exporters and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Provisions within REACH are underpinned by the precautionary principle.
- Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
- Preparation means a mixture or solution composed of two or more substances
- Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
- The substance in articles provisions within REACH applies to articles that contain hazardous substances that are likely to be released under normal or foreseeable conditions of use and which poses a danger to human health and the environment.
REACH applies to almost all the chemicals and chemical containing products except those chemicals that are exempted within REACH. REACH exemptions apply to those chemicals that do not pose hazards to human health and the environment or are adequately governed by other regulations.
Broadly speaking, REACH applies to the following:
- Organic chemicals
- Inorganic chemicals
- Specialty chemicals
- Paints and pigments
- Dyes and intermediates
- Chemical dye containing textiles
- Leather dyed with chemicals
- Biocidal products, if used for purposes other than plant protection
Why and what is exempted within REACH?
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH entered into force on 1 June 2007.The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. REACH regulation places greater responsibility on chemical industry to manage the risks from chemicals and to provide safety information on the substances. Within REACH, enterprises that manufacture or export more than one tonne of a chemical substance per year would be required to register it in a central database.
Substances which are completely exempted from REACH regulation are-
- Radioactive substances.
- Substances under customs supervision.
- Substances used in the interest of defense and covered by National exemptions.
- Non-isolated intermediates.
- Transported substances.
Substances which are exempted from Registration Requirements are:
- Food or feeding stuffs.
- Medicinal products.
- Annex IV substances.
- Annex V substances.
- Recycled or recovered substances already registered.
- Re-imported substance.
These substances are exempted from some parts of the REACH provisions, as other equivalent legislation applies to them (for example substances used in medicinal products, in food or feeding stuffs). In addition, polymers are exempted from registration (but a manufacturer will have to register monomer substances, if the polymer consists of 2% weight by weight (w/w) or more amount of monomer substance or any other substance(s) in the form of monomeric units and the total quantity of such monomer substance makes up one tonne or more per year). Re-imported substances, recycled or recovered substances that have been already registered, substances used for process and product oriented research and development (they only require a notification), non-isolated intermediates are excluded from REACH (but a special regime applies for the registration of isolated intermediates).
In addition, certain categories of substances and substances from certain identified processes, which are considered as causing minimum risk to human health and the environment, are exempt from the registration process. These substances are typically of natural origin and the lists of these exempted substances are given in Annex IV and V.
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) chemical policy has come into effect from the 1st June’ 2007 and shall impact the Indian exporters supplying to the European markets. The REACH legislation is another example of the concept of Extended Producer Responsibility being put into practice as it places the responsibility of demonstrating the safety of the items being put in the European markets on the producers. Therefore, it is but natural that the European importer shall request for the required information from his Indian supplier and this is how REACH impacts the Indian exporters.
The first obligation on the Indian manufacturers exporting to the European Union (EU) is to pre-register their item exported in quantities greater than one tonne per annum. Pre-registration also applies to companies exporting articles containing substances present in quantities of 1 tonne or more per year that are intended to be released.
Pre-registering the export items is important for all the exporters trading with the EU, since it will allow the exporters to benefit from the extended registration deadlines in REACH.
“Though pre-registration is not mandatory within REACH Directive, it is advisable to pre-register substances contained in your products to get benefited with the extended registration deadlines.
If a company does not pre-register its substance, it has to suspend its exports to EU until it will get them registered with ECHA (the Central European Chemical Agency). It is, therefore, advisable that the Indian exporters should not miss the Pre-registration deadline.”
The six months window (1st June 2008 – 30th Nov., 2008) period of pre-registration has already gone. Now there is late pre-registration provision for first time exporters.
The pre-registration can be done in two ways:
1. By direct encoding of the information on the REACH-IT website.
In order to create the pre-registration files, an add-on to the IUCLID 5 software is needed which will be made available by ECHA soon. It will be known as “IUCLID 5 Pre-registration plug-in”. It will create single as well as bulk pre-registration files for submission to REACH-IT. (On-line pre-registration)
2. By submission of a 'bulk' pre-registration prepared separately on a specified computer file format required by ECHA and uploaded at the moment of the On-line pre-registration.
Pre-registrants who do not want to use IUCLID 5 for pre-registration, still need to comply with the same data format as produced by the IUCLID 5 pre-registration plug-in. In order to enable you to develop your own tool for creating valid pre-registration files for submission to REACH-IT, ECHA has published format specifications known as “Pre-registration XML format”. The exporters can freely download this format from the ECHA website.
The information to be submitted by the exporters to ECHA during pre-registration includes:
The name(s) of the substance including:
- The names in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature or other international chemical name(s);
- Other names (usual name, abbreviation and trade name,)
- European Inventory of Existing Commercial Chemical Substances (EINECS) number (if available and appropriate);
- Chemical Abstract Service (CAS) name and CAS number (if available);
- Other identity code (if available)
- The name and address of the pre-registrant and the name of the contact person and, where appropriate, the name and address of a Third Party Representative whom the pre-registrant has selected to represent him for all the proceedings involving discussions with other Manufacturers, Importers and Downstream Users
- The envisaged deadline for registration and tonnage band
The envisaged yearly quantity shall be calculated per calendar year. For existing substances that have been exported for at least three consecutive years, quantities per year have to be calculated on the basis of the average export volumes for the three preceding calendar years.
- The name(s) of other substance(s) for which the available information is relevant for performing adaptations to the testing requirements, i.e. use of results from (Q)SAR models (Section 1.3 of Annex XI) and read-across approach
- Optionally, the pre-registrant can indicate whether he is willing to act as "facilitator" in the pre-SIEF discussions
It is important to remember that pre-registration does not include information on the composition of the substance.
Late Pre-Registration Provision
Companies exporting items that would require registration for the first time after 1st December’ 2008 can still take benefit of the extended registration deadline, provided they pre-register their new export item and submit the required information within the first six months of exporting the substance and not later than 12 months before the expiry of the registration deadline for their respective tonnage band.
First-time exporters will therefore have to submit their pre-registration before 30 November 2009 (> 1000 tonnes annual export; this provision is no longer available now), 31 May 2012 (between 100-1000 tonnes annual export) or 31 May 2017 (between 1-100 tonnes annual export), whichever is relevant in view of their tonnage thresholds.