Tag Archives: Chemical substance

Regulatory framework for the management of chemicals , European Chemicals Agency

Regulatory framework for the management of chemicals , European Chemicals Agency

Outline of the Community (European Union) legislation about Regulatory framework for the management of chemicals , European Chemicals Agency

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Institutional affairs > The institutions bodies and agencies of the union

Regulatory framework for the management of chemicals (REACH), European Chemicals Agency

Document or Iniciative

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [See amending act(s)].

Summary

The European Union (EU) has established REACH, an integrated system for the registration, evaluation, authorisation and restriction of chemicals, together with a European Chemicals Agency. REACH requires firms which manufacture and import chemicals to evaluate the risks resulting from the use of those chemicals and to take the necessary steps to manage any identified risk. Industry has the burden of proving that chemicals produced and placed on the market are safe.

The purpose of the regulation is to ensure a high level of protection of human health and the environment, and to strengthen the competitiveness of the chemicals sector and promote innovation.

Scope

The scope of the Regulation covers all substances *, whether manufactured, imported, placed on the market, or used on their own or in mixtures.

The following are excluded from the scope of the Regulation:

  • radioactive substances (covered by Directive 96/29/Euratom);
  • substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or still in transit;
  • non-isolated intermediates *;
  • the transport of dangerous substances; and
  • waste.

The rules on registration, downstream users, evaluation and authorisation do not apply to substances used in medicinal products for human or veterinary use or in food or feedingstuffs (including additives) provided they fall within the scope of Community legislation on medicinal products or food.

Registration

Registration is the key component of the REACH system. It will be compulsory to register in a central database chemicals which are manufactured or imported in quantities of one tonne or more per annum. The database will be managed by the European Chemicals Agency. If a substance is not registered it cannot be produced or placed on the European market.

Registration will be compulsory from 1 June 2008, but there will be transitional arrangements until 1 June 2018 in some cases for certain substances which must be pre-registered.

Some groups of substances (listed in the Regulation) are, however, exempt from the obligation to register, for instance:

  • polymers (however monomers which make up polymers must still be registered);
  • some substances for which the estimated risk is negligible (water, glucose, etc.);
  • naturally occurring and chemically unaltered substances;
  • substances used in research and development, under certain conditions.

Registration requires the industry (manufacturers and importers) to provide information on the properties and uses of chemicals and the precautionary measures to be taken when using them (technical dossier). The data required are proportional to the production volume of and the risks presented by the substance concerned (for example, extensive toxicity tests for substances manufactured or imported in quantities of more than 1000 tonnes). An application to register a substance which is imported or manufactured in a quantity of 10 tonnes or more per year must include a detailed description of the risks associated with that substance and the different possible exposure scenarios and risk management measures (chemical safety report).

There are “lighter” requirements for isolated intermediates, provided they are manufactured in strictly controlled conditions and for isolated intermediates which are transported and used under strict control in quantities of less than 1 000 tonnes. In these cases, only the classification, risk management measures and information already available on the properties are required. If more than 1 000 tonnes of the substance are being transported, further information is required.

Likewise, there are special arrangements for the registration of substances present in articles: given the millions of articles that are placed on the market in the EU and the potential risk some of them represent to human health and the environment, certain substances incorporated into articles must be registered. Registration is compulsory when the substance in question is normally released when the article is used and is present in those articles in quantities totalling over one tonne per producer or importer per year. For substances that are not normally released but which are particularly hazardous and are contained in a minimum concentration of 0.1% and placed on the market in quantities of over one tonne per producer or importer per year, simple notification is required, on the basis of which the European Chemicals Agency may request a registration.

The European Chemicals Agency is responsible for managing the database, receiving registration dossiers and developing technical guides aimed at helping manufacturers, importers and the competent authorities in implementing these provisions. During the first eleven years of application of the REACH system, around 30 000 substances already on the market should be registered. It is thought that about 80% of all registered substances will not need any further action.

Data sharing

The Regulation lays down a number of rules on data sharing in order to reduce testing on vertebrate animals and to reduce costs to industry. Provision is made for relevant data to be shared between registrants in exchange for payment.

To the same end, the Regulation requires all registrants of the same substance to submit their applications for registration together except in cases where there are grounds for not doing so, to protect confidential information, in case of disagreement with other registrants, or where joint submission of an application for registration involves disproportionate costs.

Information at the centre of the supply chain

Safety data will be passed throughout the supply chain so that those using chemicals in their production process to manufacture other preparations or articles will be able to do so safely and responsibly, without endangering workers’ or consumers’ health and without putting the environment at risk. This requires information to be passed both up and down the supply chain, and between all actors in that supply chain.

The data transmitted concern, inter alia, identification, composition and properties of the substances, the measures to be taken for use and transport without risk, the measures to be taken in case of fire or accidental release, and toxicological and ecological information. Sensitive information of a commercial nature does not have to be transmitted.

Downstream users

Downstream users must consider the safety of substances, based primarily on information from their suppliers, and to take appropriate risk management measures. These provisions also allow authorities to have an overview of the uses of a substance as it moves through the supply chain and, if necessary, to request further information and take appropriate measures.

Evaluation

Evaluation makes it possible for the Agency to check that industry is fulfilling its obligations and avoiding tests on vertebrate animals when unnecessary. Two types of evaluation are provided for: dossier evaluation and substance evaluation.

Dossier evaluation is to be compulsory for any applications to carry out tests specified in Annexes IX and X to the Regulation (these are the most stringent tests, mostly involving the use of vertebrate animals). The aim is essentially to minimise the need for experiments of this kind. Dossier evaluation may also be carried out in order to check the conformity of a registration. The Agency is expected to carry out a thorough review of at least 5% of the dossiers filed.

Substances suspected of posing a risk to human health or the environment may also be evaluated by the competent authorities in the Member States in order to determine whether further information is required. The evaluation programme is developed by the Agency, in cooperation with the competent authorities.

If a substance is suspected of posing a risk to human health or the environment, the Agency will include this substance in a specific list and a designated Member State will carry out an evaluation in order to determine whether further information is required from the registrant.

Evaluation can lead to the following conclusions:

  • the substance must be subject to restriction or authorisation procedures;
  • the classification and labelling of the substance must be harmonised;
  • information must be supplied to the other authorities so that they can adopt appropriate measures. For example, if, while the substance is being evaluated, information on risk management measures become available and could have an impact on the conditions of use of that substance, the information should be transmitted to the authorities responsible for this legislation.

Authorisation

Substances of extremely high concern may be subject to authorisation by the Commission with regard to particular uses. The objective is to ensure that the risks linked with these substances are validly controlled and that these substances are gradually replaced by other appropriate substances or technologies where this is economically and technically viable.

The Agency publishes and regularly updates a list of substances (‘list of candidate substances’) identified as having characteristics of extremely high concern. These may include the following:

  • CMRs (carcinogens, mutagens and reproductive toxins);
  • PBTs (persistent, bioaccumulative and toxic substances);
  • vPvBs (very persistent and very bioaccumulative substances);
  • some substances of concern which have irreversible serious effects on humans and the environment, such as endocrine disruptors.

The inclusion of candidate substances on the list involves, under certain conditions, the requirement of information on the presence of this substance in the articles. After inclusion of this substance in Annexe XIV to the Regulation any placing on the market and use of such chemical substances is subject to authorisation. This is granted if the risks arising from the substance in question can be validly controlled. If they cannot and if no alternative exists, the Commission is to assess the level of risk and the socio-economic advantages of using the substance and decide whether to authorise it or not. Some substances, such as PBTs and vPvBs can be authorised only if the socio-economic advantages override the risks and there are no alternatives.

The burden of proof is placed on the applicant. All authorisations must be reviewed after a certain period of time, determined on a case-by-case basis.

Downstream users may use a substance for an authorised use provided they obtain the substance from a company to which an authorisation has been granted and keep within the conditions of that authorisation. However, such downstream users must inform the Agency so that the authorities are fully aware of how certain substances of extremely high concern are being used.

Restriction

The restriction procedure provides a safety net, making it possible to manage the risks which are not adequately covered by other provisions of the REACH system. Proposed restrictions may relate to the conditions of manufacture, use(s) and/or placing on the market of a substance, or the possible prohibition of such activities, if necessary. They are suggested by Member States or by the Agency (at the Commission’s request) in the form of a structured dossier and decided on by the Commission.

European Chemicals Agency

The Regulation establishes a European Chemicals Agency, responsible for managing the technical, scientific and administrative aspects of REACH and ensuring consistency of decision-making at Community level.

The Agency is also to manage the registration process and play a key role in the evaluation process. It receives applications for authorisation and delivers opinions and issues recommendations in relation to the authorisation and restriction procedures.

The Agency’s headquarters are in Helsinki.

Information

Non-confidential information on chemicals is to be available, for example to allow those exposed to chemicals to take decisions as to the acceptability of the associated risks. Some information is accessible free of charge on the Agency’s website, other information on request. However, the Agency may not disclose confidential company data.

Competent authorities

The Regulation requires there to be authorities in each of the Member States with the competence and resources necessary to carry out the tasks assigned to them. These authorities must cooperate with each other and with the Agency in the performance of their duties.

Context

The previous system often proved itself to be incapable of identifying risks posed by many chemicals and was slow to act when risks were identified.

The REACH system is complemented by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. This Directive integrates the classification criteria and rules on labelling of the United Nations’ Globally Harmonized System (GHS) with Community legislation and includes the REACH provisions governing the inventory of classifications and labelling.

Key terms used in the act
  • Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Intermediate: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. There are: non-isolated intermediates (an intermediate that during synthesis is not intentionally removed from the equipment in which the synthesis takes place), on-site isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site) and transported isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites).

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1907/2006

1.6.2007
Application:
1.6.2008
1.8.2008 (Art. 135)
1.6.2009 (Title VIII and Annex XVII)

OJ L 136 of 29.5.2007

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1354/2007

23.11.2007

OJ L 304 of 22.11.2007

Regulation (EC) No 1272/2008

20.1.2009

OJ L 353 of 31.12.2008

The successive amendments and corrections to Regulation (EEC) No 1907/2006 have been incorporated into the original text.

AMENDMENTS TO THE ANNEXES

Annex II – Requirements concerning the compilation of safety data sheets
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex IV – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point a)
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex V – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point b
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex VI – Information requirements
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex XI – General rules on changes to the standard testing system
Regulation (EC) No 134/2009 [Official Journal L 46 of 17.2.2009].

Annex XIV – List of substances subject to authorisation
Regulation (EU) No 143/2011 [Official Journal L 44 of 18.2.2011].

Annex XV – Dossiers
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008].

Annex XVII – Restrictions on the manufacture, placing on the market and use of certain dangerous substances and preparations and certain dangerous articles
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008];
Regulation (EC) No 552/2009 [Official Journal L 164 of 26.6.2009];
Regulation (EU) No 276/2010 [Official Journal L 86 of 1.4.2010].

Related Acts

Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency [Official Journal L 206 of 2.8.2008].

Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 142 of 31.5.2008].

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 107 of 17.4.2008].

Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency [Official Journal L 280 of 24.10.2007].

Classification, packaging and labeling of chemicals and their mixtures

Classification, packaging and labeling of chemicals and their mixtures

Outline of the Community (European Union) legislation about Classification, packaging and labeling of chemicals and their mixtures

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

Classification, packaging and labeling of chemicals and their mixtures

Document or Iniciative

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 [See amending act(s)].

Summary

This Regulation harmonises requirements concerning the classification, labelling and packaging of chemical substances and mixtures in line with the international system approved by the United Nations. This harmonisation enhances protection of health and the environment, and improves the free circulation of chemical substances and mixtures.

Enterprises must classify, label and pack their substances and mixtures in line with the provisions of this Regulation before putting them on the market.

Scope

The Regulation covers chemical substances and mixtures which are composed of two chemical substances or more.

The Regulation does not apply to:

  • radioactive substances and mixtures covered by Directive 96/29/Euratom;
  • substances subject to customs supervision which are in temporary storage, in a free zone or free warehouse with a view to re-exportation or still in transit;
  • non-isolated intermediates (substances which are manufactured in order to be chemically transformed into another substance);
  • substances and mixtures for scientific research and development which are not placed on the market;
  • waste;
  • medicinal products;
  • cosmetic products;
  • some medical devices;
  • food;
  • the transport of dangerous goods.

Classification

The classification of chemical substances and mixtures is based on categories which take into account the degree of hazard and the specific nature of the hazardous properties. These include inflammable substances or mixtures, those which are highly toxic, those which are dangerous for the aquatic environment, etc. Annex I establishes the criteria for the classification and labelling of hazardous substances and mixtures.

The Annexes of the Regulation also include the list of hazard statements, the list of precautionary statements, pictograms for each hazard class and the lists of classifications and labelling harmonised at Community level.

Labelling

Labelling must mention:

  • the name of the substance or mixture and/or an identification number;
  • the name, address and telephone number of the supplier;
  • the nominal quantity of the substance or mixture.

If applicable, labelling must include:

  • hazard pictograms (see Annex V of the Regulation);
  • the signal words “Danger” or “Warning”;
  • hazard statements such as “Fire or projection hazard”, “Fatal if swallowed”, etc. (see Annex III of the Regulation);
  • precautionary statements such as “Keep only in original container”, “Protect from moisture”, “Keep out of reach of children”, etc. (see Annex IV of the Regulation);
  • supplemental information, for example on physical properties or health hazards (see Annex II of the Regulation).

Hazard pictograms shall be in the shape of a square set at a point. They shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. Each hazard pictogram shall cover at least one fifteenth of the surface area of the harmonised label and the minimum area shall not be less than 1 cm2.

The dimensions of the label shall be as follows:

Capacity of the package Dimensions (in millimetres)
Not exceeding 3 litres If possible, at least 52 × 74
Greater than 3 litres but not exceeding 50 litres At least 74 × 105
Greater than 50 litres but not exceeding 500 litres At least 105 × 148
Greater than 500 litres At least 148 × 210

The label for the hazardous substance or mixture shall be written in the official language(s) of the Member State where it is placed on the market, unless the Member State concerned provides otherwise.

Hazard pictograms, signal words, hazard statements and precautionary statements shall be located together on the label in an order established by the supplier, provided that the statements are grouped by language.

Packaging

Packaging containing hazardous substances or mixtures shall comply with the following requirements:

  • packaging must prevent any of the contents escaping;
  • packaging must be made of materials which are resistant if they come into contact with the contents;
  • packaging must be strong and solid;
  • packaging must have sealable fastenings.

In some cases, child-resistant fastenings and tactile warnings are required.

Harmonisation procedure

In order to trigger the harmonisation procedure for the classification and labelling of substances, Member States, or even manufacturers, importers or downstream users, can submit a proposal for the harmonised classification and labelling of substances, containing the information set out in Annex VI, Part 1 of this Regulation to the European Chemicals Agency. Generally, only substances satisfying the classification criteria for Category 1 respiratory sensitisation, mutagenicity, carcinogenicity or reproductive toxicity, or active ingredients in pesticides or biocides will be subject to such harmonisation, but other substances may be subject thereto if a necessity for harmonisation is demonstrated.

Within eighteen months from receipt of the proposal, the risk assessment committee of the Agency shall give an opinion on the proposal.

The Agency shall send this opinion to the Commission which, if it considers that harmonisation is appropriate, will include the substance and its classification and labelling elements in Annex VI, Part 3 of this Regulation.

The classification and labelling inventory

At the latest one month after having placed a substance on the market, the manufacturer or importer shall notify the Agency of information concerning its identity, the identity of the substance, hazard classes, concentration limits, etc. All this information shall be included in an inventory of classification and labelling that the Agency shall update on a regular basis.

Context

This Regulation supplements the REACH system for registration, assessment, authorisation and restrictions concerning chemical substances.

This Regulation amends Directive 67/548/EEC on chemical substances and Directive 1999/45/EC on mixtures and repeals them with effect from 1June 2015.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1272/2008

20.1.2009
1.12.2010 (Titles II, III and IV for substances)
1.6.2015 (Titles II, III and IV for mixtures)

OJ L 353, 31.12.2008

Amending act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 286/2011

19.4.2011

OJ L 83, 30.3.2011

AMENDMENTS TO THE ANNEXES

Annex I – Classification and labelling requirements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex II – Special rules for labelling and packaging
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex III – List of hazard statements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex IV – List of precautionary statements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex V – Hazard pictograms
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex VI – List of harmonised classification and labelling of hazardous substances
Regulation (EC) No 790/2009 [Official Journal L 235 of 5.9.2009];
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annexe VII – Translation table
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].