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What is REACH?

The European Union Regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on June 1, 2007, replacing previous chemicals regulations in the EU, and is being implemented in the period 2008 – 2018. Under REACH, companies operating in the EU face obligations for substances that they manufacture, import, supply, and/or use. REACH was specifically designed to place the responsibility on industry to demonstrate safe use and show why hazardous substances should continue to be used. The European Chemicals Agency (ECHA) is administering the requirements.

REACH places substantial obligations on manufacturers and importers of substances (including importers of articles that contain substances intended to be released), including registering each substance manufactured or imported in quantities of 1 tonne or above per year. Unregistered substances may not be manufactured or imported after the applicable registration deadline.

Downstream users are also affected, both directly and indirectly. Although downstream users do not have direct registration obligations, they need to provide information to suppliers on use and exposure to support the registration process. They also must report to ECHA in certain circumstances and prepare their own chemical safety reports (CSRs) for any continued uses outside conditions described in the revised safety data sheet (SDS). Downstream users must communicate information up the supply chain when they gain new information on hazardous properties of the substance or the appropriateness of risk management measures in the SDS supplied to them. Downstream users may need to change some chemical management practices in order to comply with safety measure in news SDSs. Finally, many downstream users will be affected as supplies of chemicals are affected—some chemicals will become more expensive and others may disappear from the market altogether.

REACH contains provisions for a list known as Annex XIV, Substances of Very High Concern (SVHC). For these substances, authorization must be sought for their continued use, which requires a technical dossier, a socio-economic analysis, and proof that there is no suitable alternative for the application to be provided. An Annex XIV substance cannot be manufactured, used or placed on the market unless authorized, and the authorization, if granted, will be subject to time limits and conditions. REACH also imposes reporting and downstream communication requirements on suppliers of certain articles that contain SVHC.

Enforcement of REACH is on a country-by-country basis. All EU countries may impose Administrative penalties and fines for REACH violations, and many are prepared to use additional enforcement measure such as ordering suspension of business activity, closure of the premises, withdrawal of a permit, suspension or ban on use of a substance, suspension of placing on the market of a substance, destruction of a substance, and so forth. In some countries, REACH violations are subject to criminal penalties including fine and imprisonment.

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Substances

 

The European Union Regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) entered into force on June 1, 2007, replacing previous chemicals regulations in the EU, and is being implemented in the period 2008 – 2018. Under REACH, companies operating in the EU face obligations for substances that they manufacture, import, supply, and/or use. REACH was specifically designed to place the responsibility on industry to demonstrate safe use and show why hazardous substances should continue to be used. The European Chemicals Agency (ECHA) is administering the requirements.

Substance is defined as 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.

Some materials are totally exempt from REACH:

  • Radioactive substances
  • Non-isolated intermediates
  • Substances under customs supervision
  • Waste

ECHA will maintain an inventory of registered substances, with a registration number for each. ECHA has issued detailed Guidance for identification and naming of substances under REACH, which addresses how substances are identified and named for purposes of REACH, including criteria for determining if substances are the same.

 

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

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Articles

 

An article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition. Packaging is generally considered a separate article from its contents.

Registration
An article producer or importer must submit registration for a substance if the following conditions are met:

  • The substance is intended to be released from the produced and/or imported articles during normal or reasonable foreseeable conditions of use.
  • The total amount of the substance present in all articles produced and/or imported, from which the substance is intended to be released, exceeds 1 tonne per year.
    • The amounts intended to be released as well as the amounts which are not intended to be released or are not released at all need to be counted.
    • If different types of article with intended release are produced and/or imported, the quantities in all articles with intended release need to be summed.
Note:  A substance does not have to be registered by the article producer or importer if it has already been registered for that use.

Notification
An article producer or importer must submit notification to ECHA in some cases.

Notification is required when all of the following conditions are met: However no notification is required if any of the following conditions are met:
  • The substance is included in the Candidate List of SVHC
  • The substance has already been registered for the use in the article by another company.
  • The substance is present in articles produced and/or imported at a concentration above 0.1% (w/w).
  • The articles have only been produced and/or imported by the producer/importer before the substance was included in the Candidate List.
  • The total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% (w/w) of the substance, exceeds 1 tonne per year for the producer/importer.
  • There is no exposure of the substances to humans or the environment during normal or reasonably foreseeable conditions of use including disposal.  (This determination is difficult and costly to make.)

 

Article notification requirements started on June 1, 2011.  A required notification is due six months after a substance has been added to the Candidate List. Notifications require information including identity information for the notifier, registration number, substance identity and classification, description of use of the substance in the article, and tonnage range. Notification is accomplished through IUCLID and REACH-IT.

Communication
Article 33 of REACH requires suppliers of articles to inform the recipient and consumers if an article contains any of the substances on the Candidate List of SVHC above 0.1% (by weight per article). Suppliers of such articles have to provide relevant safety information about the substance available to them to the recipients of these articles—at a minimum the name of the substance. REACH does not specify the format for the information.  Possible formats include labels, use instructions, or a website. Information available to the article supplier necessary to ensure safe use of an article must be provided to consumers upon request, within 45 days and free of charge. There are no tonnage triggers, and the communication obligations apply to articles that were produced or imported before the substance was included in the Candidate List, but are supplied after the inclusion on the list. The following summary table is from ECHA’s Guidance in a Nutshell.

 

Obligation: Registration of substances in articles Notification of substances in articles Communication of information on substances in articles
Legal basis in REACH Article 7(1) Article 7(2) Article 33
Actors concerned article producers and article importers article producers and article importers article suppliers
Substances concerned substance intended to be released from articles substance included in Candidate List of SVHCs substance included in Candidate List of SVHCs
Tonnage threshold 1 tonne per year 1 tonne per year NA
Concentration in article threshold NA 0.1% (w/w) 0.1% (w/w)
Exemption for substance already registered for that use yes yes no
Exemption when exposure can be excluded no yes no

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Registration

REACH requires manufacturers and importers to generate data on the substances they manufacture or import, to use the data to assess risks and to develop risk management measures to address the risks of the substances. The data and assessments must be provided to ECHA in the form of a Registration Dossier. Only registered substances (or those exempt from registration) can be legally on the market in the EU.

What is Registration?
Registration is the duty of the manufacturer of a substance or the importer of a substance on its own or in a mixture. The registrant must be a legal entity in the EU, and a third party or industry association may not register. There is a process for non-EU entities that manufacture substances, or produce mixtures and articles outside the EU (to enter commerce in the EU) to appoint an only representative within the EU to register a substance imported into the EU.

Registration Obligations
Registration obligations apply for substances manufactured or imported in quantities of 1 tonne or more per year, with different obligations for phase-in versus non phase-in substances.

 

Phase-in

 Non Phase-in
  • Phase-in substances were already being manufactured or placed on the market before REACH entered into force on June 1, 2007. These substances generally can be registered under transitional deadlines as long as they were pre-registered between June 1, 2008 and December 1, 2008. The transitional deadlines vary based on tonnage (per manufacturer or importer) and chemical hazard properties.
  • Non phase-in substances (and phase-in substances that were not pre-registered) must be registered before they can be manufactured, imported, or placed on the market in the EU, unless exempt.

Manufacturers and importers have the obligation to collect available information on the intrinsic properties of a substance and to provide information in a registration dossier according to information requirements laid out in REACH annexes. Annexes VII to X specify the standard information requirements according to four tonnage bands from 1 tonne per year to ≥ 1000 tonnes per year. The general scheme to be followed by registrants involves gathering and sharing existing information, assessing information needs based on tonnages and exposures, identifying information gaps, and generating new information as necessary (e.g., by testing).

  • In general, REACH registration dossiers contain information on substance identity, physicochemical properties, mammalian toxicity, ecotoxicity, environmental fate, manufacture and use scenarios, and risk management measures. The dossier, submitted through the IUCLID system, contains a technical dossier and a Chemical Safety Report (CSR) for substances manufactured or imported in a quantity of 10 tonnes or more per year.
    • The CSR is the document reporting the Chemical Safety Assessment (CSA). The CSA incorporates both hazard assessment and exposure assessment to arrive at risk characterization and risk management measures, and is developed iteratively in cooperation with others in the supply chain.
  • ECHA has developed various guidance documents on how to generate a CSR and registration dossier, including a detailed Guidance on information requirements and chemical safety assessment.

Registration Exemptions.
Some substances are exempt from registration (or covered under reduced requirements):

  • Polymers (but their monomers and other bound substances must be registered)
  • Substances/groups named in Annex IV, certain low risk substances
  • Substances falling within Annex V exemptions (e.g. unrefined natural substances, substances that result from certain incidental reactions, hydrates, and others)
  • Substances to the extent used in food or pharmaceuticals
  • Recycled or recovered substances already registered
  • Reimported substances
  • Substances used for research and development
  • Isolated intermediates
Note: Some substances are exempt from REACH altogether. Also, active substances for use in biocides and plant protection products, as well as some substances notified under the previous directive 67/548/EEC, are regarded as registered. 

Data Sharing
REACH provisions include processes for sharing data among registrants, to reduce animal testing and costs. Sharing is allowed for all types of data and required for data collected through vertebrate animal testing.
 

Phase-in Non Phase-in
  • For a phase-in substance, data sharing is accomplished through a Substance Information Exchange Forum (SIEF) established based on pre-registration of the substance.
  • For non phase-in substances, an inquiry dossier is required to determine whether a registration or another inquiry has already been submitted for the same substance, so that data sharing mechanisms can be established as appropriate.

ECHA has issued a Guidance on data sharing.

Suppliers must provide safety data sheets (SDSs) to all downstream users and distributors for substances classified as hazardous according to the EU CLP Regulation or as dangerous mixtures under Directive 1999/45/EC, for PBT or vPBT substances, and for substances on the Candidate List. For a mixture or substance for which an SDS is not required, the supplier still has to communicate certain information (outlined in Article 32) to downstream users and distributors by the time of first delivery.

The registrant must submit a notice of classification and labeling to ECHA:
  • if the substance is subject to registration, but has not yet been registered, or
  • if the substance is within the scope of the CLP Regulation, meets the criteria for classification as hazardous and is placed on the market either on its own or contained in a hazardous mixture above specified concentration limits.

Detailed information on CLP requirements is available on the ECHA website CLP section.

Registrants need to update their registrations when they obtain new information on the substance or dossier information, including changes in the tonnage band or cessation of manufacture or import. Updates may also be required as a result of decisions under the evaluation procedure.

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Evaluation

Substance evaluation under REACH aims to determine whether the uses of a substance pose a risk to human health or the environment. There are two main evaluation mechanisms under REACH.

Testing Proposal Examination
Substance evaluation is carried out by Member State Competent Authorities (MS-CAs), with ECHA in a coordination role. In the testing proposal examination, ECHA examines testing proposals to check that reliable and adequate data will be produced, and to prevent unnecessary animal testing.

  • ECHA issues draft decisions within specified timeframes that vary for phase-in and non phase-in substances. Registrants and downstream users have the right to comment on the draft decision before it is finalized, and MS-CAs may propose amendments.
  • Possible decisions include accepting or rejecting the testing protocol, or accepting or rejecting it with conditions (e.g., requiring more testing).

Compliance Check
During the compliance check, ECHA checks a registration dossier to ensure that the legal requirements of REACH are fulfilled, the quality of the submitted dossier is sufficient, the safety assessment is suitably documented in a Chemical Safety Report (CSR), the proposed risk management measures are adequate, and that any explanation to opt out from a joint submission of data has basis.

  • If the dossier is found not to comply, EPA prepares a draft decision requiring the registrant to submit any necessary information to bring it into compliance.Possible decisions include accepting or rejecting the testing protocol, or accepting or rejecting it with conditions (e.g., requiring more testing).
  • ECHA performs the compliance check on a sample of the dossiers it receives, with both random-based and criteria-based selection of which dossiers to check.

Substance evaluation is triggered by risk-based concerns after an evaluation of hazard, exposure, and tonnage data. Substance evaluation involves assessment of information from all registrants of the same substance. ECHA prioritizes substances for evaluation and lists them in a Community Rolling Action Plan (CoRAP).

  • Within 12 months of the publication of the CoRAP, the MS-CA must complete a substance evaluation (unless time is extended because additional information is required).ECHA performs the compliance check on a sample of the dossiers it receives, with both random-based and criteria-based selection of which dossiers to check.
  • MS-CAs may propose substances to be added to the CoRAP.
  • ECHA plans to submit the first proposal for the CoRAP to the Member States by December 1, 2011. In 2012, 40 substances should be evaluated, increasing to 50 substances per year after that.

Substance evaluation is part of an iterative process of data collection and data review, starting with an initial concern and ending with a decision on how to address the concern. The outcome of substance evaluation is a decision on whether sufficient information is available to clarify the risk-based concern, with the possibility of a decision to request further information. If a concern remains, there may be voluntary action by registrants or downstream users to address the concern. Otherwise, the MS-CA may conclude that action should be taken under the authorization, restriction, or classification and labelling procedures in REACH, that information should be passed to other authorities responsible for relevant legislation, or that no further action is needed. Registrants and downstream users have the right to comment on draft decisions before they are finalized.

The evaluation process may trigger restrictions (i.e., conditions for or prohibitions of manufacture, use or placing on the market of a substance), which may be accomplished through an Annex XV dossier prepared by ECHA and/or a MS.
 

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

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Authorization

The authorization process applies for substances of very high concern (SVHC) that are placed on the Authorization List (REACH Annex XIV). SVHC that are included on the Candidate List go through a prioritization procedure to determine which will be included on Annex XIV. The authorization process is intended to ensure that these substances are properly controlled and progressively replace by suitable alternatives.

A substance on the Authorization List cannot be placed on the market or used after its designated sunset date. Unless specific exceptions apply, a substance on the Authorization List may be placed on the market only if an authorization has been granted for a specific use, or the use has been exempted from authorization.

Authorization List
Manufacturers, importers or downstream users of a substance on the Authorization List may prepare and submit applications for authorization.

  • Authorization requires demonstrating that risks associated with use of a substance are adequately controlled or that the socio-economic benefits outweigh the risks.Possible decisions include accepting or rejecting the testing protocol, or accepting or rejecting it with conditions (e.g., requiring more testing).
  • An application includes a specification of the use applied for, a Chemical Safety Report, and analysis of alternatives, a substitution plan, and may include a socio-economic analysis.

Risk Assessment
The ECHA Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) review the application. The committees prepare their draft opinions within 10 months of receipt of the application. The RAC and SEAC send their opinions to the European Commission, which prepares the draft decision.

  • Applicants have the opportunity to comment on the draft opinions before the opinions and authorization decision are finalized.
  • The whole process takes well over a year.

European Commission
If the European Commission authorizes the use of the substance, the holder of the authorization must comply with its requirements.

  • The holders of the authorization must update the Safety Data Sheet and include the authorization number on the label.
  • Downstream users may use chemicals that have been authorized by a party further up the supply chain, but must comply with the conditions set out in the authorization and notify ECHA of their use of the substance.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

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Downstream Users

Using a substance or preparation in an industrial or professional context is a downstream use. Potential downstream user activities include refilling and re-importing, as well as the variety of uses that occur in industrial and professional settings. Consumer use and use of articles is not downstream use. However, the use of substances to produce articles is downstream use, and producers of Articles have some particular obligations under REACH.

Registration Process
Substance registration under REACH will be conducted in phases during the period 2008 – 2018, and thereafter for new chemicals. Work with the suppliers to make sure they are aware of your use and will include it in the registration dossier as appropriate. Meanwhile, suppliers may be seeking information from you to prepare their registrations and to develop exposure scenarios.

REACH registration and other requirements
DUs must not place on the market or use any substances that are not registered in accordance with REACH.

 

This means that your products may contain only substances that are:

REGISTERED

REGISTRATION EXEMPT

Pre-registered and have a registration deadline in the future

Produced/imported by the supplier in amounts below 1 tonne/year.

Contact the supplier to determine and request written confirmation of REACH status. There is a list of registered substances on the ECHA website. There also is a list of pre-registered substances on the ECHA website.


DUs also need to comply with any restrictions imposed through the evaluation and authorization processes under REACH. The supplier will indicate if and when these restrictions apply, usually in the SDS. For substances subject to authorization, you will have to comply with any conditions covering your use and possibly apply for an authorization if your use is not covered by an authorization granted to the supplier.

Safety Data Sheet
Over time, REACH will increase the amount of information you receive from suppliers, e.g., on safety data sheets (SDSs). Follow instructions in the SDSs that you receive. DUs must apply appropriate measures to control risk communicated in SDSs or in any other information supplied to them.

Exposure Scenario
SDSs for substances that meet certain hazard and quantity criteria will have attached exposure scenarios—a new SDS feature under REACH. The exposure scenario will contain a description of the subject use and information on how the substance or preparation may be used safely, including specified risk management measures (RMMs). It is the DU's responsibility to check that your use is consistent with the exposure scenario and take action if it is not. Your use is covered when your actual operational conditions and risk management measures correspond to those specified in the exposure scenario.

Use outside the exposure scenario
The following are available options when your use of a substance or preparation varies from the exposure scenario in the extended SDS:

  • make your use/use conditions known to your supplier so that the supplier can prepare an exposure scenario covering your use conditions;
  • change your conditions of use so they comply with the supplier's exposure scenario;
  • find another supplier who provides an exposure scenario covering your conditions of use;
  • prepare your own chemical safety report; or
  • stop using the substance/preparation and find an alternative.

There also are some exemptions that may apply, e.g., for research uses and uses below certain tonnage levels, but in these cases a report to ECHA may be required.

Formulator or refiller?
A formulator mixes substances and/or preparations to make preparations to place on the market. A refiller transfers substances or preparations from one container to another. Note that if chemical reaction occurs during mixing, you may be a manufacturer under REACH and thus subject to additional obligations.

Hazards and safe conditions of use
Formulators and refillers (which are DUs) that supply substances or preparations must recommend appropriate measures to control risk. They must provide SDSs as required under REACH, and communicate certain information (e.g., that a substance is subject to restriction or authorization) by other means if an SDS is not required. When compiling its own SDS, a DU needs to include relevant exposure scenarios and use other relevant information from upstream SDSs supplied. Consider the REACH and CLP requirements in detail if you are a DU developing your own SDSs for substances or preparations that you distribute to others.

New information on hazards or RMM.
DUs must inform suppliers of any new information they obtain on hazards of a substance, including information related to classification and labeling. New information means information that was not communicated by the supplier and is not available in public databases or literature. New information on hazards can include, but is not limited to, new information about physicochemical properties, stability and reactivity, toxicology, ecological effects, and so forth.

If you have new information that influences classification and labeling and thus would classify the substance differently than the supplier, you have to report this to ECHA, unless you use less than 1 tonner per year of the subject substance.

DUs must also tell suppliers about information they have regarding the appropriateness of risk management measures (RMMs) in exposure scenarios. This could include, for example, knowledge that the RMMs are not effective, that the RMMs address exposure routes that do not occur, or that they contradict classification and labeling.
 

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

Related 

Substances of Very High Concern (SVHC)

Substances fulfilling one or more of the criteria defined in REACH Article 57 can be identified as “substances of very high concern” (SVHC). Substances that may be designated as SVHC include:

  • substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 or 2;
  • substances for which there is evidence for similar concern, such as endocrine disruptors. 
  • persistent, bioaccumulative and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances; or

SVHC are identified by Member States and placed on the Candidate List.  Addition of a substance to the Candidate List triggers legal obligations throughout the supply chain.

ECHA prioritizes substances on the Candidate List, to determine which substances should be subject to authorization.  Prioritization results in decisions regarding: 

  • the “sunset date” by when a substance can no more be used without authorizisation. 
  • whether or not the substance will be subject to authorization; 
  • which uses of the included substances will not need authorization (e.g. because sufficient controls established by other legislation are already in place); and

REACH contains notification and communication requirements for SVHC in articles.  Suppliers of Candidate List substances and preparations containing them need to provide customers with safety data sheets. 

ECHA publishes a registry of intentions that identifies substances which might be listed as SVHC (before they are included in the Candidate List).

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

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