GHS
The birth of GHS globally has created massive chemical safety awareness encouraging other countries to implement even more stringent chemical regulations for ensuring chemical safety. Most countries have embraced this new positive change by making chemical safety priority and others are yet to follow.
United Nation, UN, have gone ahead to create a Globally Harmonised System for classification and labelling of chemicals. This chemical regulatory system aim's to communicate safe use of chemicals to workers and consumers, transport and disposal. Some countries have adopted and implemented GHS system into their chemical regulations. The purple book provides at least the minimum requirement or the foundation for a harmonised system for chemicals.
To see countries GHS implementation status, click here . Some countries have implemented GHS by incorporating the system into an already existing national chemical regulations.
EUROPE GHS implementation EEA have gone a step further by introducing a system that allows manufacturers and importers register products imported or manufactured at >=1 tonne per annum providing chemical safety assessment and report for substances >=10 tonnes per annum. The procedure for registration on substance in the EU must comply with REACH regulation 1907/2006 where substances are then Registered, Evaluated and where necessary Authorised for a specified used and Restricted for use.
Dossiers are submitted by registrants and harmonised classification for each substance is published on the classification and labelling inventory on ECHA website.However, the classification published represents the minimum classification for a particular substance and careful consideration must be taken when using such classification for any substance instead of the manufacturer or importer's Classification reported in the safety Data Sheet (SDS). Classification of substances must be compliant with the CLP regulation Regulation EC 1272/2008 which is in line with GHS system.
REACH history in EU
For all phase-in substances i.e.exisiting substances
Born 1st June 2007
- Pre-registration deadline 1st June 2008 -1 Dec 2008
- Chemical Manufactured or imported at >=1000 tonnes per annum, chemicals classified as carcinogens, mutagens and reproductive toxicants (CMR's) manufactured or imported at >=1 tonne per annum and chemicals very toxic to aquatic organisms ( R50/53 now H400 and H410) manufactured or imported at >=100 tonnes per annum, registration deadline 30th Nov 2010
- Chemical Manufactured or imported at >=100 -1000 tonnes per annum registration deadline 31st May 2013
- Chemical Manufactured or imported at >=1-100 tonnes per annum registration deadline 31st May 2018 Phase-in substances that missed pre-registration cannot enjoy the benefits extended registration deadline, therefore must be registered immediately.
However, all non-Phase-in substances i.e. new substances must be registered immediately before being placed on the EU market. First time manufacturers or importers of >=1 tonne per annum can still benefit from the extended registration by submitting a late preregistration. What next after the registration deadline in May 2018?All manufacturer's or importer must register substances manufactured or imported at >= 1 tonnes per annum before placing on the market.
CLP in EU
Classification of hazardous substances involves initial hazard identification by determining the intrinsic properties of the substances or mixtures which is then assessed to determine the potential to cause harm. Each identified hazard is checked against the criteria set in Annex I of the CLP and a hazard class(es) will be allocated to the substance or mixture. List of harmonised classification can be found in Annex VI of the CLP regulation. The 3 hazard classes includes Physical Hazard, Health Hazard and Environmental Hazard each hazard will require data such as physiochemical properties, toxicological data and ecotoxicological data respectively to properly assess the substance or mixture accurately.
Physical Hazards: This data are usually easier to obtain and are cheaper to perform if out sourced from an external laboratory. REACH guidance Chapter R 7a provide details on the necessary Endpoints required for CSA
Health Hazard: The data obtained for the various endpoints are more expensive to perform and are usually conducted using laboratory animals. However, few human data's are available from epidemiology studies. Several in vivo assays have been approved for some endpoints such as Skin corrosion and skin sensitization. REACH guidance Chapter R7aprovide details on the necessary Endpoints required for CSA
Environmental Hazards : The data obtained for various endpoints care also expensive to perform. Detailed information can be obtained from Chapter R7b and Chapter R7c
Data sharing has been encouraged by REACH for all Registrants with aim to achieve one classification for one substance. We are yet to see this become consistent within the EU, given that the harmonised classification represents only a minimum classification for a registered substance hence the likelihood of having different classification for one substance still exists.
Labelling of substances is conducted once the substance has been classified. Label is used to communicate the hazard of the substance to the user. Pictograms, signal words, Hazard and Precautionary statements and supplementary statements are used to communicate the hazard class of a substance or mixture. Guidance on labelling and packaging can be obtained from this link . Usually, the labelling information is included in section 2 of the SDS and the on product packaging
Packaging of hazardouss chemicals should be safety proofed to prevent or reduce risk of exposure to anyone around the chemical when stored. CLP regulation has set out rules for packaging hazardous chemicals and guidance can be downloaded from this link.
Poison Centre in EU
The chase for chemical safety in Europe, Article 45 of the CLP regulation requires EU countries to set up appointed bodies to collect information of chemicals placed on the market. Downstream users and importers who place such chemicals on the EU market must provide information on the chemical composition and associated hazard to the appointed body. This enables information of the chemical to be communicated to any medical or health professional seeking information in the event of an accident. Read more. Proposed Annex VIII for harmonized information relating to emergency health response is still being considered.
LIST OF CHEMICAL REGULATIONS APPLICABLE TO UK
Supply
- REACH-
- BPR
- CLP
- Cosmetics Regulation
- Food Additive Regulations
- Ecolabel in products and product groups
- Textile regulation
- Pesticides Agriculture
- COPR for profuctd not regulated by BPR
Use
LIST OF TITLES and ANNEXES in REACH regulation (EC) No 1907/2006.
REGISTRATION -
Title II covers registration of substances (Articles 5-24), Title III covers data sharing and testing avoidance (Article 25- 30), Title IV provides Information in supply chain (Article 31-36), Title V provides legal obligation for down stream users ( Article 37-39).
EVALUATION-
Title VI covers Evaluation of chemicals (Article 40-54)
AUTHORIZATION -
Title VII provides obligations for when Authorization of chemical is required (Article 55-66)
RESTRICTION -
Title VIII provides guidance for Restriction on manufacturing or importation of some dangerous chemicals mixtures or article (Articles 67-73)
OTHERS-
Title IX - fees and charges
Title X- Agency
Title XI- Information
Title XIII- competent Authority
Title XIV - Enforcement
Title XV- Transitional and final Provisions
ANNEX I
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
ANNEX II
REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS
ANNEX III
CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
ANNEX IV
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)
ANNEX V
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)
ANNEX VI
INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ANNEX VII
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE
ANNEX VIII
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE
ANNEX IX
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE
ANNEX X
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE
ANNEX XI
GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN
ANNEXES VII TO X
ANNEX XII
GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
ANNEX XIII
CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
ANNEX XIV
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION
ANNEX XV
DOSSIERS
ANNEX XVI
SOCIO-ECONOMIC ANALYSIS
ANNEX XVII
RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES
LIST OF TITLES and ANNEXES in CLP regulation (EC) No 1272/2008.
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