IB2 Flashcards
Countries in the United Nations, including those in the European Union, have been working together with industry representatives and others to agree a classification and labelling system that can be used worldwide. The outcome is
The Globally Harmonised System of Classification and Labelling of Chemicals, known as the ‘GHS’. The GHS provides a single system to identify hazards and to communicate them in transporting and supplying chemicals across the world i.e. label and safety data sheets
European Union (EU) Member States agreed to adopt the GHS across the EU through a direct acting Regulation
The Classification, Labelling and Packaging of Substances and Mixtures. This is also known as the ‘CLP Regulation’ or just ‘CLP’
In addition to CLP the European Commission presented a proposal for a new EU regulatory system for chemicals
REACH, which stands for: Registration Evaluation Authorisation of Chemicals
All chemicals will require EU authorisation by ________ before the materials are allowed to be sold or imported within the EU. Their use may also be restricted
the European Chemical Agency (ECHA)
REACH is an EU Regulation that covers all chemicals (with a few exceptions) if they are manufactured or imported into the EU in quantities of _________
1 tonne or above
REACH is designed to
Improve information in the supply chain - many substances are data poor and this can lead to inadequate risk assessments.
Promote better risk management measures.
Facilitate compliance with CoSHH.
Encourage the use of safer alternatives for CMR substances.
Allow the free movement of substances on the EU market.
Question the need for animal testing.
Lead to improvements in Occupational health.
Under REACH, each producer and importer of chemicals in volumes of 1 tonne or more per year will have to register each chemical with the EU Chemicals Agency (ECHA), submitting information on:
The general technical, commercial and administrative information needed for all registrations is
specified in Annex VI of the REACH Regulation. This includes the following key information:
1) General information on the registrant
2) Identification of the substance
3) Information on the manufacture and use(s) of the substance
4) Classification and labelling of the substance
5) Guidance on safe use
6) Exposure information for substances in quantities of 1 to 10 tonnes.
CMR
CMRs are substances classified as Carcinogenic, Mutagenic or toxic to Reproduction, category 1 or 2, in accordance with
Directive 67/548/EEC. (‘Classified in accordance with Directive 67/548/EEC’ refers to substances listed in Annex VI of
the CLP Regulation with a harmonised classification and labelling and substances self-classified by the registrant).
Through REACH evaluation, public authorities will look in more detail at registration dossiers and at substances of concern
Completeness check
Compliance check
Dossier evaluation
Substance evaluation
Under REACH, the authorisation procedure aims to assure that the risks from Substances of Very High Concern are properly controlled and that these substances are progressively replaced by suitable alternatives while ensuring the good functioning of the EU internal market.
Substances with the following hazard properties may be identified as Substances of Very High Concern (SVHCs):
Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction
Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB)
Substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances
A comparison between the approach of REACH and CoSHH
Although REACH places responsibility for the identification and assessment of chemical hazards and risks on those ultimately responsible for their manufacture or importation into the EU, this does not change the responsibility COSHH places on employers for assessing risks and deciding how to control them in the individual workplace. This means downstream users are now faced with two sets of obligations under REACH and COSHH.
The intention of the CLP Regulation is
before placing chemicals on the market, the industry must establish the potential risks to human health and the environment of such substances and mixtures, they should be classified, labelled and packaged appropriately. But because CLP adopts CHS, in time, the same classifications and labelling will be used throughout the world.
CHIP is a set of UK Regulations that
was were revoked from 1 June 2015 and no longer have legal effect. Chemical suppliers should comply with the CLP Regulation.
COSHH Regulations 2002 Amended by (The Classification, Labelling and Packaging of Chemicals
(Amendments to Secondary Legislation) Regulations 2015) defines a substance hazardous to health” means a substance (including a mixture) as
(a) which meets the criteria for classification as hazardous within any health hazard class laid down in the CLP Regulation whether or not the substance is classified under that Regulation
(b) for which the Health and Safety Commission has approved a maximum exposure limit or an occupational exposure standard;
(c) which is a biological agent;
(d) which is dust of any kind, except dust which is a substance within paragraph (a) or (b) above, when present at a concentration in air equal to or greater than—
(i) 10 mg/m3, as a time-weighted average over an 8-hour period, of inhalable dust, or
(ii) 4 mg/m3, as a time-weighted average over an 8-hour period, of respirable dust;
(e) which, not being a substance falling within sub-paragraphs (a) to (d), because of its chemical or toxicological properties and the way it is used or is present at the workplace creates a risk to health;
CLP
EC Regulation No 1272/2008 Classification, Labelling and Packaging or Substances and Mixtures (CLP)