- Hazardous Substances
- International Hazardous Substances Regulations
- Restriction of the Use of Certain Hazardous Substances (RoHS)
- Placing on the market and use of hazardous substances
- Legal provisions and deadlines stipulated in the REACH regulation
- Seveso III Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances, amending Council Directive 96/82/EC
International Hazardous Substances Regulations
Many countries in the world have put in place regulations which aim at controlling the manufacturing and the use of chemical substances with the objective to limit adverse effects on human health and environment. For instance: the Canadian Environmental Protection Act (CEPA), the China REACH, the “Toxic Substances Control Act” (TSCA), the Biocidal Product Regulation, the REACH regulation (CE N°1907/2006).
Restriction of the Use of Certain Hazardous Substances (RoHS)
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive (2011/65/EU) aims to prevent hazardous substances from entering the production process and thereby keep them out of the waste stream.
Placing on the market and use of hazardous substances
Regulatory context in the European Economic Area
Note: for information on Hazardous Substances Regulations in non-European countries, see here.
In the European Economic Area context:
- The Regulation (EC) No 1272/2008, known as the CLP Regulation (Classification,
Labelling & Packaging) came into force in January 2009. This regulation lays down
obligations to be respected concerning the classification, labelling and packaging of
- The directive 2011/65/EU, known as the RoHS directive – relating to the restriction of the
use of hazardous substances in electrical and electronic equipment entered into force on
21 July 2011. This Directive lays down rules on the restriction of the use of certain
substances (Cadmium, Mercury, Chromium VI, Lead, PBB, PBDE). Further substances
could be concerned (HBCDD, 3 phtalates).
- The regulation (EU) N° 517/2014, known as fluorinated greenhouse gases Regulation
came into force on 1st January 2015. The purpose of this Regulation is to protect the
environment by reducing emissions of fluorinated greenhouse gases. (see below)
- The Regulation (EC) No 1907/2006, known as the REACH Regulation (Registration, Evaluation & Authorization of CHemicals) came into force in June 2007. This regulation which is applicable in the European Economic Area, lays down obligations to the manufacture, the placing on the market, the use and prohibition of substances. The principal provisions and deadlines concerning this regulation are set out in the information about the legal provisions and deadlines stipulated in the REACH regulation below.
In this last case, the Regulation (EC) No 1907/2006 lays down the following obligations:
- The manufacturers and importers of chemical substances shall, under certain
conditions, register their substances. This involves identifying their dangers and
evaluating the risks of using them throughout their life cycle.
- The substances which cause the most concern called SVHC (Substances of Very
High Concern) are subject to authorization provisions, restriction on the use
and/or duties to communicate, whether they are present in mixtures or in the
The regulation (EU) N° 517/2014 established:
- Rules on containment, use, recovery and destruction of fluorinated greenhouse
- Conditions on the placing on the market of specific products and equipment that
contain fluorinated greenhouse gases,
- Conditions on specific uses of fluorinated greenhouse gases,
- Quantitative limits for the placing on the market of hydrofluorocarbons.
- The regulation (EU) N° 528/2012, known as Biocide Product Regulation, entered into
force on 1st September 2013. The new Regulation on biocidal products contains provisions
which apply not only to biocidal products but also to all articles considered as a “treated
article”. A Treated Article (also imported article) is a substance, mixture or article which
has been treated with, or intentionally incorporates, one or more biocidal products.
Regulatory context in oher European Countries
Federal law n° 52-fz.
Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU
REACH regulation does not apply in this country.
Switzerland has its own chemical regulations adopting REACH-like registration
requirements, and SVHC in articles communication duties.
The provisions governing the obligation to notify, declare and register new substances
and provisions governing the obligation to communicate the presence of Substances of
Very High Concern (SVHC)- REACH Candidates list, are contained in its Chemicals
Ordinance on Protection against Hazardous Substances and Preparations (known as
Anyone who commercially supplies an article containing a substance of very high concern
in a concentration greater than 0.1% by weight must provide a declaration to the
The provisions on the restriction of the marketing and uses of certain substances,
preparations and articles are governed by another ordinance Chemical Risk Reduce
Legal provisions and deadlines stipulated in the REACH regulation
1 June 2007:
- REACH entered into force.
- Title IV REACH “Communication in the supply chain” applies.
By 1 June 2008:
- Registration of non phase-in substances on their own, in mixtures or intended to be released from articles before they are manufactured/imported/put on the market.
- Title V REACH “Downstream User’s obligations” applies.
- Title VII REACH “Authorization” applies, including procedures establishing candidate list for authorization (Article 59 REACH).
- Duty to communicate information on substances of very high concern present in articles and included in the candidate list to article recipient/consumer upon request under certain conditions (Article 33 REACH).
- Title IX REACH “fees and charges” applies.
By 1 January 2009:
- Publication on Agency website of pre-registered phase-in substances with first envisaged registration deadline (Article 28.4 REACH).
- First recommendation for a priority list of substances for authorisation to be issued by the Agency (Article 58.3 REACH).
By 1 June 2009, Title VIII REACH “Restrictions” applies – repeal of Directive 76/769/EEC.
From 1 June 2008 until 30 November 2010, registration of:
- Substances classified as “CMR”, category 1 and 2 in quantities of 1 tonne/year and above per manufacturer/importer.
- Substances classified as very toxic to aquatic organisms (R50/53) in quantities of 100 tonnes/year and above per manufacturer/importer.
- Other substances on their own, in mixtures or intended to be released from articles in quantities of 1000 tonnes/year and above per manufacturer/importer (Article 23.1 REACH).
As of 1 June 2011, notification of substances in articles (Article 7.2 REACH) 6 months
after they have been included in the candidate list (Article 7.8
From 1 June 2008 until 31 May 2013: Registration of substances on their own, in mixtures or intended to be released from articles in quantities of 100 tonnes/year and above per manufacturer/importer (Article 23.2 REACH).
From 1 June 2008 until 31 May 2018: Registration of substances on their own, in mixtures or intended to be released from articles in quantities of 1 tonne/year and above per manufacturer/importer (Article 23.3 REACH).
European Manufacturers, authorised representatives, importers and distributors of electrical and electronic equipment within the scope of RoHS need to comply with the directive.
If you consider or have reason to believe that a product you are responsible for does not comply with the directive you must meet certain requirements which include:
- notifying market surveillance authorities,
- informing the supply chain, and
- taking remedial action.
Seveso III Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances, amending Council Directive 96/82/EC
The key areas of change are:
- Scope – due to the move from the classification system ‘Chemicals (Hazard Information and Packaging for Supply)’ (CHIP) to the new classification system ‘Classification, Labelling and Packaging’ (CLP).
- Public Information – all COMAH sites to make certain information about their sites and hazards permanently and electronically available to the public.
Other areas of change relate to safety reports, notifications, emergency plans, some changes in definition of key terms (eg presence of dangerous substances) and broader duties in relation to domino effects, particularly sharing information with neighbouring sites.
In the UK, new regulations, titled ‘The Control of Major Accident Hazards Regulations 2015’ implemented all but the land use planning aspects and Article 30, ‘Heavy Fuel Oils’ of Council Directive 2012/18/EU (Seveso III Directive) on the control of major-accident hazards involving dangerous substances. Article 30 has already been implemented in Great Britain via a consequential amendment to the COMAH Regulations 1999, this change will be incorporated into the COMAH Regulations 2015.