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Regulations

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Background

Recent Changes

 

Background

The hazard determination and communication requirements for supply of products containing dangerous materials in the European Union are now contained in two core regulations:

  • The Classification, Labelling & Packaging, (CLP) Regulation (EC) No 1272/2008
  • The REACH Regulation (EC) No 1907/2006

These have direct legal impact in each Member State and replace a series of directives that ceased to have legal effect on 1st June 2015

The Classification, Labelling and Packaging (CLP) Regulation establishes the UN Globally Harmonised System as it will apply in Europe.  This defines the classification criteria used for determination of physical, health and environmental hazards of a material and specifies the pictograms, hazard statements and precautionary statements that must be shown on a supply label. A set of official EU-harmonised classifications according to CLP may be found in Table 3.1 of Annex VI.  A number of amending regulations have already been issued to take account of updates to the GHS system and changes to the harmonised classification table.

The requirements for Safety Data Sheets are established in Annex II to the REACH Regulation, as currently published in Commission Regulation (EU) 2015/830 and is effective from 1 June 2015.  SDS prepared under earlier requirements and showing classifications under both CLP and the previous classification system may still be used up until 31 May 2017.

Restrictions on Marketing and Use may be found in Annex XVII tof the REACH Regulation.

Other directives that still apply to the safe use and disposal of hazardous materials include:

  • Chemical Agents in the Workplace Directive 98/24/EC

  • Control of Major Accidents involving Dangerous Substances 96/82/EC

  • Hazardous Waste Directive 91/689/EEC

Regulations for supply outside the EU are now converging as various countries adopt the GHS.  However, as the GHS does not require counties to adopt all the building blocks of the system, some differences in requirements will remain.  Nevertheless the final outcome will see a significantly more harmonised system for hazard communication throughout the world.

Separate regulations apply to the transport of dangerous goods. As they are based on UN Model Regulations for the Transport of Dangerous Goods, effective global harmonisation has already been achieved.  There is also a large degree of harmony between the different transport modes (road, rail, sea and air).  The actual regulations are set out in the:

  • IMDG Code - Maritime transport

  • ICAO-TI or IATA Dangerous Goods Regulations - Air Transport

  • ADR - Road Transport in Europe

  • RID - Rail Transport in Europe

  • DOT Regulations 49 CFR - US Transport Regulations

 

 

Recent Changes

Update of hazard determination and communication regulations is a dynamic process that is driven by developments in technical progress, availability of new data and the desire to achieve greater harmonisation between systems. The most important recent changes are summarised as follows:

Commission Regulation (EU) 2015/830
This regulation contains the current version of  Annex II to the REACH Regulation.  It specifies detailed requirements for Safety Data Sheets in the European Union, including the use of mandatory subsection headings.  It applies to all SDS issued after the 1st June 2015 and allows a further two years to bring existing SDS into compliance with the requirements, which essentially means removal of information according to the previous classification system. 

ADR 2015 Applicable from January 2015

  • Instructions in writing revised again! Updated version not mandatory until July 2017  
  • Provisions adopted for the transport of adsorbed gases  
  • Environmentally hazardous substances UN 3077 & UN3082 in receptacles ≤ 5 L may be carried exempt from the regulations
  • Updated provisions for some wastes - lithium batteries including damaged batteries, discarded packaging  

IMDG Code 2014, mandatory from January 2016

  • Adopts changes outlined above under ADR, except for discarded packaging and instructions in writing
  • Introduction of codes for stowage, segregation and handling

OSHA HAZCOM 2012
This update of 29 CFR 1910.1200 marks the adoption by the US of the GHS as the hazard communication standard for the workplace with a transition deadline of June 2015.

Classification, Packaging, Labelling Regulation (EC) No 1272/2008
The regulation was published in December 2008 and introduces the UN Globally Harmonised System for hazard communication.  A number of ATPs to the harmonised classifications have already been published.  Manufacturers and importers of chemicals must notify their classifications of substances to the Classification and Labelling Inventory, which are published by the European Chemicals Agency (ECHA) on their website.

REACH Regulation (EC) No 1907/2006
After considerable discussion and negotiation, the final REACH regulation was published in the Official EU Journal on the 18th December 2006.  This requires manufactures and importers to go through a process for

  • registration,
  • evaluation and
  • authorisation of chemicals,
    subject to quantity thresholds.

A Fundamental element is that all existing chemicals being placed on the EU market in excess of 1 Ton per enterprise per annum must now be registered.  Registration requires the submission of the same type of information as was previously only required for notification of new substances i.e. substances placed on the market after 1981.  Responsibility for registration rests with the Manufacturers of chemical substances in the EU and Importers who import either substances or products containing substances from outside the EU.  Non-EU manufacturers may appoint an EU-based Only Representative to prepare registrations on their behalf, and thus maintain access to EU markets. 

Various phase in periods are allowed, depending on the quantities and hazards involved.  Potential registrants had to Pre-register between 1st June 2008 and 1st December 2008 in order to avail of the phase-in period and have the opportunity to share registration costs with other registrants.  Manufacturers/importers new to the market may still avail of the phase in period for the 1-100 ton bracket under late pre-registration provisions.

A number of materials have been identified as substances of very high concern (SVHC) and are moving through the regulatory restriction process which will eventually require granting of specific authorisations for continued use.


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