REACH services at Rivendell

Some of the specialist services that Rivendell offers for REACH include:

• Act as "only representative" for non-EU based companies in the registration process.
• Act as a "third party representative" for companies that wish to remain anonymous during the registration process allowing confidential business information to be retained.
• Assessment of chemical inventories for compliance of upstream and downstream actors in the supply chain.
• Review of available data packages to identify data gaps and suitability of data for submission ('data gap analysis').
• Review of data and properties of active substance as part of a 'feasibility study' to ascertain the potential success of a submission.
• Analysis of chemical portfolios for classification and labelling purposes and identification of SVHC.
• Recommendations to address data deficiencies (using public domain data, scientific waivers, QSARs, read-across, new data generation or data access).
• Development of data waivers and reasoned scientific justifications for non-submission of data, where appropriate.
• Design, implementation and completion of cost-effective testing programmes, to generate new studies to fill data gaps: management of study programmes from single studies to large programmes involving several test facilities at different global locations.
• Risk assessments for human health and the environment, including the development of approaches where Emission Scenario Documents (ESDs) are not available.
• Preparation, compilation, submission and follow-up in relation to whole or part dossiers.
• Preparation of Chemical Safety Assessments (CSA) and Chemical Safety Reports (CSR).
• Preparation of IUCLID 5 dataset.
• Representation of clients in meetings with EU regulatory authorities and at EU Evaluation Meetings.
• Liaison with the authorities throughout evaluation.
• Representation of clients in data access negotiations with other companies or task forces.
• Task force (SIEF) co-ordination, participation and management.
• MSDS preparation and updates.
• Literature searches, chemical database searches and reviews of public domain data.
• Rivendell also provides REACH training seminars on-site at individual companies, at public venues throughout Ireland, and in other EU Member States through our Spanish, Benelux and Slovenian offices.

Important notice to Non-European based manufacturers!

If you are a non-European based manufacturer having an interest in importing substances on your own, in preparations or articles you will have to appoint a natural or legal person established in the Community as your Only Representative. The Only Representative will have to fulfil all obligations of the importer under the REACH Regulation.

Rivendell offers to become your Only Representative and be your liaison with the European authorities. Rivendell has the background required in the practical handling of substances and information related to them and is able to keep available up-to-date information on quantities imported and customers sold to as well as information on the supply of the latest update of the safety data sheets.

As your Only Representative Rivendell will pre-register your substances. In addition Rivendell can take care of representing you in Substance Information Exchange Forums (SIEF's) and support you with the registration of your substances.

Your obligations under REACH

• Manufacturers (M): produce substances
• Importers (I): import substances from non-EU countries
• Downstream users (DUs): make articles using chemicals or use chemicals professionally.

Manufacturers & Importers (M/I):

• Must register each substance manufactured or imported within the EU in quantities of >1 tpa per M/I.
• Must communicate information down the supply chain.

• Must ensure their uses are covered in the exposure scenario of the Safety Data Sheet (SDS) communicated to them. Must implement the risk management measures (RMMs) assigned for the chemicals they use.
• Must communicate information up and down the supply chain.

REACH is the new EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. It officially entered into force on the 1st of June 2007. The objective of REACH is to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH switches responsibility for the control and safety of chemicals from authorities, to those that manufacture, import and use chemicals. REACH therefore has implications for manufacturers, importers, formulators, distributors and users of chemicals, as well as those producing and/or importing articles.

The following REACH-related topics are covered in greater detail below:

• The key aspects of REACH
• What are the objectives of REACH?
• Why is REACH needed?
• To what and whom does REACH apply?
• What are the major deadlines under REACH?
• Why come to Rivendell?
• Useful REACH-related links
• Glossary of terms and acronyms
  
  
  

  The key aspects of REACH
  
  

  • Greater responsibility will fall on actors throughout the supply chain. REACH reverses responsibility for assessing chemical risks onto manufacturers and importers, rather than regulators.
  • The European Chemicals Agency (ECHA), which is located in Helsinki, will manage the Regulation in co-operation with Member State (MS) Competent Authorities.
  • All substances within the scope of REACH that are either manufactured in or imported into the EU at quantities > 1 tonne per manufacturer/importer per year, will have to be registered.
  • Introduction of a "no data, no market" provision, prohibiting manufacture or placing on EU market of substances for which registration risk-assessment data packages have not been submitted. Owners of data are entitled to compensation for 12 years from others referring to their data.
  • 'Existing' substances are to be registered on a phased basis and within certain quantity thresholds.
  • The authorities will carry out annual in-depth evaluations (i.e. assessments) of substances flagged as being of potential high risk (e.g. on the basis of information provided at registration).
  • The uses of substances of very high concern [e.g. CMRs (carcinogens, mutagens, and substances toxic to reproduction), PBTs (persistent, bioaccumulative, and toxic) and vPvBs (very persistent, very bioaccumulative)] may need to be authorised.
  • Manufacture or use of high risk substances may be subject to restriction.
  • Data sharing is encouraged for each substance under a "one substance, one registration" rule, with penalties for those who opt out.
  • It is mandatory to share data derived from vertebrate animal testing in order to minimise the amount of such testing necessary.
  
  
  

  What are the objectives of REACH?
  
  The aims of REACH are to:
  

  • Improve the protection of human health and the environment.
  • Maintain and enhance the competitiveness of the EU chemicals industry.
  • Promote alternative methods for the assessment of hazards of substances.
  • Promote non-animal testing.
  • Ensure the free circulation of substances on the internal market of the EU.
  • Increase transparency within the chemical industry.
  • Conform with EU International obligations under the WTO.
  
  
  REACH replaces about 40 pieces of legislation with a streamlined and improved Regulation. Other legislation regulating chemicals (e.g. on cosmetics, detergents) or related legislation (e.g. on health and safety of workers handling chemicals, product safety, construction products) not replaced by REACH will continue to apply. REACH has been designed not to overlap or conflict with other chemicals legislation.
  
  
  

  Why is REACH needed?
  
  

  • Over 30,000 substances on the EU market are imported / manufactured / used in quantities of = 1 tonne per annum (tpa).
  • Very limited information is available on the hazards and risks to human health and the environment as a result of the use of these chemicals.
  • There has been increasing public concern over the risks of chemicals and as a result there is a need for a better evidence base to address this concern.
  • Until the entry into force of the REACH Regulation, the existing regulatory system has been very slow to produce results - less than 200 substances have been assessed properly over the past 30 years.
  • This system was also made up of over 40 pieces of legislation which was confusing for industry to understand and for authorities to administer. REACH pulls all the necessary aspects of these Directives and Regulations into one piece of legislation.
  
  
  

  To what and whom does REACH apply?
  
  

  • REACH applies to the manufacture, placing on the market or use of substances on their own, in preparations or in articles and to the placing on the market of preparations.
  • Registration requirements apply to substances manufactured or imported in quantities above one tonne per year. Registration is applicable per legal entity, which means that larger companies may register several times for each of their manufacturing or importing sites.
  • Although certain exemptions exist, in general, REACH applies to all types of chemicals, not just those used in industrial processes but also in day-to-day life, for example in varnishes, cleaning products and paints as well as in articles such as furniture, clothes, printer cartridges and electrical appliances.
  • Some substances are exempted from the overall scope of REACH (e.g. radioactive substances and substances under customs supervision) while others are exempted from certain provisions (e.g. substances used in medicinal products).
  • Provisions on classification and labelling, authorisation and restrictions are applicable to all substances manufactured or placed on the EU market regardless of volume, if they are considered to be dangerous.
  • New substances and any that fail to be accepted as "phase-in" substances must meet the registration requirements under REACH with immediate effect. The data to be submitted depend on the tonnage being produced or imported.
  • Substances that are proven to have been placed on the EU market or manufactured in the EU at least once in the 15 years prior to entry into force of the Regulation are eligible for "phase-in" registration deadlines, providing they are pre-registered (free of charge) in a six-month window from 1 June to 1 December 2008.
  • Substances manufactured or imported in quantities > 10 tpa require a chemical safety report containing risk management measures.
  • Substances in articles are required to be:
    • registered, if the substance is present in quantities > 1 tonne per producer or importer per year and the substance is intended to be released under normal conditions;
    • notified to the European Chemicals Agency (the ECHA) if the substance meets criteria requiring it to be authorised and is on the candidate list for authorisation. This applies only if it is present in quantities > 1 tonne per producer or importer per year and the substance is present in those articles above a concentration of 0.1% w/w. It does not apply if the producer or importer can exclude exposure to humans or the environment during normal conditions of use including disposal and supplies appropriate instructions for safe use of the article.
  
  
  

  What are the major deadlines under REACH?
  
  

  • 1st June 2007 - REACH entered into force
  • 1st June 2008 - European Chemicals Agency (ECHA) officially in operation and the main titles of REACH apply
  • 1st June 2008 - Non-phase in substance registration
  • 1st June 2008 - 1st December 2008 - Pre-registration for phase-in substances
  • 1st January 2009 - 1st June 2018 - Participation in Scientific Information Exchange Forum (SIEF)
  • November 2010 - 1st phase-in substance deadline for pre-registered substances > 1000 tpa
  • June 2013 - 2nd phase-in substance deadline for pre-registered substances > 100 tpa
  • June 2018 - 3rd phase-in substance deadline for pre-registered substances > 1 tpa
  
  
  

  Why come to Rivendell?
  
  It is widely recognised that REACH will require significant scientific and regulatory expertise from the chemical industry. Fortunately, Rivendell has an existing global team of regulatory consultants with many years experience in regulatory affairs. This team includes in-house experts in the fields of human health (toxicology, biochemistry), environmental fate, ecotoxicology and chemistry. We draw upon our existing experience to support our clients under REACH.
  Through our involvement in the review of biocidal substances under the Biocidal Products Directive (BPD) we have been involved in developing approaches to exposure scenarios, in the same way as is applied to chemicals. The human health and environmental risk assessments for biocidal products are also based on approaches used in the review of chemicals under the HPVC programme, and we have completed many such risk assessments for our clients. We have prepared many IUCLID datasets for the EU authorities, and have considerable expertise in dossier preparation and submission, classification and labelling and MSDS preparation. Our experts evaluate the quality of data and prepare expert waivers for non-submission of studies (where relevant). Where it is not possible to waive a study, we recommend test facilities that can conduct the study in a cost-effective manner, and we design, implement and ensure completion of such study programmes at test facilities worldwide.
  An important element of REACH is the formation of substance information exchange fora (SIEFs), to manage co-operation and data sharing between companies. We deal with task forces on a day-to-day basis through the course of our normal regulatory projects; working at all levels from client representation to task force co-ordination and management. We also represent clients at meetings with national regulatory authorities and European Commission scientific institutions. With our existing track record of assisting companies with regulatory legislation and our wealth of directly relevant experience, we believe that Rivendell is your perfect partner in your REACH compliance programme.

Regulation EC 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals – Official REACH Regulation Document

European Chemicals Agency – Official website for the ECHA

European Chemicals Bureau – latest information on draft REACH Implementation Projects (RIPs) and other technical documents relating to REACH

Health and Safety Authority – Ireland – Official website for the Governmental body responsible for REACH implementation in Ireland

European Commission Environment Directorate – Policy documents and Q&As on REACH

European Commission Enterprise Directorate – Policy documents on REACH

EU Member State helpdesks – Contact information for REACH helpdesks in the Member States

IUCLID 5 – EU chemical database (including downloadable software)

European Chemical Substances Information System (ESIS) – EU inventory of substances, data, classification and labelling

OECD eChemPortal – Database on properties of chemicals

United Nations Economic Commission for Europe (UNECE) - Globally Harmonised System (GHS) of Classification and Labelling of Chemicals information website

European Commission REACH / GHS – Implementation of GHS and related documents

For other useful links to guidance documents, impact reports and Q&A’s, please click here

Agency: The European Chemicals Agency (ECHA) will be in charge of the day-to-day management of REACH.
Article: Manufactured object with a special shape, surface or design which determines its function to a greater degree than its chemical composition, e.g. an printer cartridge releasing toner or a ballpoint pen releasing ink.
Authorisation: Use-specific permission to use a substance of very high concern.
C&L: Classification and Labelling
Competent Authority (CA): The authority or authorities or bodies established by the Member States to carry out their obligations arising from the REACH system.
CMR: Abbreviation for several groups of substance of very high concern, namely those which are carcinogenic (cause cancer), mutagenic (cause damage to genes) or reproductively-toxic (cause either a decrease in fertility or problems with development of the foetus). CMRs are classified in three categories according to the weight of scientific evidence of damages to human health. Only category 1 and 2 substances for which there is a high level of evidence of health damage to humans are subject to authorisation under REACH.
CSA: Chemical Safety Assessment
CSR: Chemical Safety Report
DNEL: Derived No Effect Level
Downstream User (DU): Companies that use substances professionally or industrially (on their own or in preparations). Example: a manufacturer who mixes different chemicals to make ink, or uses the ink to print leaflets.
Endocrine disrupters: Substances of very high concern that mimic or inhibit the effects of hormones. They will be identified on a case-by-case basis and may become subject to authorisation. Many of these substances are also CMRs.
ECB: European Chemicals Bureau
ECHA: European CHemicals Agency
EIF: Entry Into Force
EINECS: European INventory of Existing Chemical Substances
ELINCS: European LIst of Notified Chemical Substances
EUSES: European Union System for the Evaluation of Substances
Existing chemicals: Chemicals that were reported to be on the market in 1981, when the requirement to notify new chemicals entered into force. There are about 100,000 existing chemicals. According to estimations, some 30,000 of them will be subject to registration in REACH.
GHS: Global Harmonisation System of Classification and Labelling of Chemicals
GLP: Good Laboratory Practice
HPVC: High Production Volume Chemicals
IBEC: Irish Business and Employers Confederation
Identified use: Any particular use of a substance that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user.
Intermediates: Chemicals that are used up in the process of making other chemicals.
In vitro testing: Studies done with cell or tissue cultures (as opposed to in vivo testing, where live animals are used).
IUCLID: International Uniform ChemicaL Information Database
JRC: Joint Research Centre
LPVC: Low Production Volume Chemicals
MS: Member State
New chemicals: Chemicals that have been placed on the market since 1981. These have to be notified to the Competent Authorities under the current EU chemical legislation. There are around 4000 ‘new’ chemicals currently on the market and these are considered to be pre-registered under REACH.
OECD: Organisation for Economic Co-operation and Development.
OR: Only Representative
OSOR: One Substance One Registration
PBT: Persistent, Bioaccumulative & Toxic
Phase-in substances: substances listed in the EINECS list (European Inventory of Existing Commercial Chemical Substances) or those that have been manufactured in the Community but not placed on the Community market in the last 15 years or the so-called 'no-longer' polymers' of Directive 67/548/EEC.
PIC: The Rotterdam Convention on Prior Informed Consent sets up a system to control international trade in certain hazardous substances.
PNEC: Predicted No Effect Concentration
Polymers: Large molecules consisting of repeated chemical units (monomers) joined together. Examples of polymers: plastic materials, two-component glue. Polymers are exempt from registration under REACH, but monomers are not.
POPs: Persistent Organic Pollutants banned under UNEP’s Stockholm Convention.
PPORD: Product and Process Orientated Research and Development
PPP: Plant Protection Product
Preparation: Mixture or solution composed of two or more substances.
pTGD: Preliminary Technical Guidance Document
QSAR: Quantitative Structure-Activity Relationship
RCR: Risk Characterisation Ratio
REACH: Registration, Evaluation and Authorisation of Chemicals
Registrant: The manufacturer or the importer submitting a registration.
Registration: The first administrative step of REACH. The manufacturers and importers submit information in a standardised format, to demonstrate that they know about the most important properties of their chemicals and that they are managing their risks adequately.
RIP: REACH Implementation Project
Risk: The risk posed by a substance depends on hazard (the intrinsic properties of the substance) and exposure.
RMM: Risk Management Measure
SDS: Safety Data Sheet
SEA: Socio Economic Analysis
SIEF: Substance Information Exchange Forum
SPORT: Strategic Partnership on REACH Testing
Substances in articles: Hazardous substances that are released from articles as part of their function will generally have to be registered. If the release is not intentional, only substances of very high concern have to be notified.
Substitution: Avoiding the use of a hazardous substance by replacing it with another substance (a substitute) or by changing production methods.
Sustainable development: Development that meets the needs of the present without jeopardising the needs of future generations. Sustainable development includes striking the right balance between environmental, social and economic concerns.
SVHC: Substances of Very High Concern
TGD: Technical Guidance Document
Tonnage threshold: Volume-based criteria for different requirements under REACH, formulated as “X tonnes per year and per manufacturer/importer”. The tonnage thresholds are used to define registration deadlines.
Toxicity: Property of chemical causing adverse effects on humans, animals or plants (e.g. causes cancer or death).
vPvB: very Persistent, very Bioaccumulative