Regulations

Supply Regulations

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 applies 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 been issued to take account of updates to the GHS system, changes to the harmonised classification table and the introduction of criteria for classification of endocrine disrupting properties. 

The regulation also governs the requirements for notifications to the Classification and Labelling Inventory and EU-harmonised poison centre notifications.  The latter requires that the detailed formulation of mixtures that present physical or health is submitted to a centralised database maintained by the European Chemicals Agency (ECHA) and that a Unique Formula Identifier (UFI) is displayed on the label.

The requirements for Safety Data Sheets (SDS) are established in Annex II to the REACH Regulation, as currently published in Commission Regulation (EU) 2020/878. This update applied from 1 January 2021 and among other changes introduced some mandatory sub-headings relating to endocrine disrupting properties.  SDS prepared under previous Annex II amendments are no longer valid.

Restrictions on Marketing and Use may be found in Annex XVII to the REACH Regulation.  At it core, the regulation deals with the Registration, Evaluation and where necessary the restriction of chemicals placed on the EU market

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 aspiration is to see a significantly more harmonised system for hazard communication throughout the world.

Transport Regulations

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

Other Safety Regulations

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 2012/18/EU

  • Waste Directive 2008/98/EC

  • There are also a range of product-specific regulations such as  aerosols, detergents, biocides, and medical device regulations.