This document provides an overview of the key provisions of REACH, the new European Union chemical regulatory scheme. REACH will require chemical manufacturers and importers to register substances and provide safety data. It establishes provisions for evaluating chemicals of concern, restricting or authorizing high-risk substances, and communicating safety information down the supply chain. The European Chemicals Agency will administer REACH and coordinate with EU member states on enforcement.
New Product Registration - Key Considerations when Registering New ProductsCovance
The regulation related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was adopted by the EU in 2007 in response to worldwide initiatives to address the impact of chemicals on human health and the environment. REACH requires all manufacturers and importers of chemicals into European markets to assess and manage the risks associated with their substances and products, and register them with the European Chemicals Agency (ECHA). To manage this project, ECHA split existing substances into three categories, based on the amount of the substance that is used annually, with different registration deadlines for different tonnages of use.
Seminar: Effects of EU bilateral trade agreements on agriculture and food sectors, 16.12.2016, Helsinki (Ministry of Agriculture and Forestry)
Mr Matti Aho, Director General, Finnish Food Safety Authority EVIRA
New Product Registration - Key Considerations when Registering New ProductsCovance
The regulation related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was adopted by the EU in 2007 in response to worldwide initiatives to address the impact of chemicals on human health and the environment. REACH requires all manufacturers and importers of chemicals into European markets to assess and manage the risks associated with their substances and products, and register them with the European Chemicals Agency (ECHA). To manage this project, ECHA split existing substances into three categories, based on the amount of the substance that is used annually, with different registration deadlines for different tonnages of use.
Seminar: Effects of EU bilateral trade agreements on agriculture and food sectors, 16.12.2016, Helsinki (Ministry of Agriculture and Forestry)
Mr Matti Aho, Director General, Finnish Food Safety Authority EVIRA
Practical steps to implement the Integrated Chemical Safety and Security Program in Ukraine were proposed at Ukraine Chemical Security Forum, held in Kielce, Poland, on April 19, 2016, in the framework of CHEMSS2016.
Slides for the eLearning course Separation and purification processes in biorefineries (https://open-learn.xamk.fi) in IMPRESS project (https://www.spire2030.eu/impress).
Section: Mass transfer processes
Subject: 3.3 Safety issues
Standards and related issues in the WTO Agreement on SPS and TBTFAO
Ahmad Mukhtar
Economist -Trade and Food Security, FAO Liaison Office Geneva
Materials of the workshop on Resolving agricultural trade issues through the WTO organized by FAO in collaboration with Ukraine’s Ministry of Agrarian Policy and Food of Ukraine in Kyiv on June 7, 2017.
http://www.fao.org/economic/est/est-events-new/wtokiev/en/
http://www.fao.org/europe/news/detail-news/en/c/892730/
Introduction to the EU REACH Program and California’s Green Chemicals Initiative - REACH & Beyond: Workshop on the Changing Nature of Chemicals Management - December 15, 2008, Sunnyvale, California
REACH - Evaluation and Registration - Vid ČopiVidopi
Here is the English version of the presentation I gave on the 21st of November 2018 on REACH, summarising the upcoming dossier evaluation process and describing cases in which a company's status as a manufacturer or importer of substances is not immediately obvious.
Are you responsible for keeping up to date with legislation on chemicals in products? This presentation brings you all the latest regulatory news on chemicals in products from around the world.
Chemicals covered include BPAs, phthalates, lead, cadmium, formaldehyde, PFOA, TCEP and other chemicals of high concern across a wide range of products from jewelry to infant formula, food packaging to batteries, and toys.
Stakeholder presentation at the ESPP stakeholder meeting on STRUBIAS and EU Fertilisers Regulation (05/09/2018) organised by the European Sustainable Phosphorus Platform (ESPP, www.phosphorusplatform.eu)
More workshop outcomes at:
https://phosphorusplatform.eu/activities/conference/meeting-archive/1728-espp-stakeholder-meeting-on-strubias-and-eu-fe
EU Fertiliser Regulation dossier by ESPP can be found at: http://phosphorusplatform.eu/regulatory
On December 18, 2006, the European Parliament passed the final REACH Directive. Work on this legislation began in 2003. REACH will begin to be phased in on June 1, 2007.
REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States. Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations.
This regulatory briefing provides a summary of some of the key elements and concepts of the REACH Directive. For more information on EH&S and product responsibility services, go to:
http://calthacompany.com/compliance-programs-ems-auditing
Jukka Malm: European Regulatory Framework for Chemicals - Protecting Citizens...THL
Jukka Malm, Deputy Executive Director, European Chemicals Agency (ECHA), at Europe That Protects - Safeguarding Our Planet, Safeguarding Our Health EU side event, 3-4 Dec 2019, THL, Helsinki
The Australia Group is an informal arrangement which aims to allow exporting or transshipping countries to minimise the risk of assisting chemical and biological weapon (CBW) proliferation. The Group meets annually to discuss ways of increasing the effectiveness of participating countries’ national export licensing measures to prevent would-be proliferators from obtaining materials for CBW programs.
Participants in the Australia Group do not undertake any legally binding obligations: the effectiveness of their cooperation depends solely on a shared commitment to CBW non-proliferation goals and the strength of their respective national measures
Practical steps to implement the Integrated Chemical Safety and Security Program in Ukraine were proposed at Ukraine Chemical Security Forum, held in Kielce, Poland, on April 19, 2016, in the framework of CHEMSS2016.
Slides for the eLearning course Separation and purification processes in biorefineries (https://open-learn.xamk.fi) in IMPRESS project (https://www.spire2030.eu/impress).
Section: Mass transfer processes
Subject: 3.3 Safety issues
Standards and related issues in the WTO Agreement on SPS and TBTFAO
Ahmad Mukhtar
Economist -Trade and Food Security, FAO Liaison Office Geneva
Materials of the workshop on Resolving agricultural trade issues through the WTO organized by FAO in collaboration with Ukraine’s Ministry of Agrarian Policy and Food of Ukraine in Kyiv on June 7, 2017.
http://www.fao.org/economic/est/est-events-new/wtokiev/en/
http://www.fao.org/europe/news/detail-news/en/c/892730/
Introduction to the EU REACH Program and California’s Green Chemicals Initiative - REACH & Beyond: Workshop on the Changing Nature of Chemicals Management - December 15, 2008, Sunnyvale, California
REACH - Evaluation and Registration - Vid ČopiVidopi
Here is the English version of the presentation I gave on the 21st of November 2018 on REACH, summarising the upcoming dossier evaluation process and describing cases in which a company's status as a manufacturer or importer of substances is not immediately obvious.
Are you responsible for keeping up to date with legislation on chemicals in products? This presentation brings you all the latest regulatory news on chemicals in products from around the world.
Chemicals covered include BPAs, phthalates, lead, cadmium, formaldehyde, PFOA, TCEP and other chemicals of high concern across a wide range of products from jewelry to infant formula, food packaging to batteries, and toys.
Stakeholder presentation at the ESPP stakeholder meeting on STRUBIAS and EU Fertilisers Regulation (05/09/2018) organised by the European Sustainable Phosphorus Platform (ESPP, www.phosphorusplatform.eu)
More workshop outcomes at:
https://phosphorusplatform.eu/activities/conference/meeting-archive/1728-espp-stakeholder-meeting-on-strubias-and-eu-fe
EU Fertiliser Regulation dossier by ESPP can be found at: http://phosphorusplatform.eu/regulatory
On December 18, 2006, the European Parliament passed the final REACH Directive. Work on this legislation began in 2003. REACH will begin to be phased in on June 1, 2007.
REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States. Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations.
This regulatory briefing provides a summary of some of the key elements and concepts of the REACH Directive. For more information on EH&S and product responsibility services, go to:
http://calthacompany.com/compliance-programs-ems-auditing
Jukka Malm: European Regulatory Framework for Chemicals - Protecting Citizens...THL
Jukka Malm, Deputy Executive Director, European Chemicals Agency (ECHA), at Europe That Protects - Safeguarding Our Planet, Safeguarding Our Health EU side event, 3-4 Dec 2019, THL, Helsinki
The Australia Group is an informal arrangement which aims to allow exporting or transshipping countries to minimise the risk of assisting chemical and biological weapon (CBW) proliferation. The Group meets annually to discuss ways of increasing the effectiveness of participating countries’ national export licensing measures to prevent would-be proliferators from obtaining materials for CBW programs.
Participants in the Australia Group do not undertake any legally binding obligations: the effectiveness of their cooperation depends solely on a shared commitment to CBW non-proliferation goals and the strength of their respective national measures
Animal testing safety endpoints in chemical industryMIHIR PUJARA
This presentation describes animal testing safety end points in chemical industry according to REACH(registration,evaluation,authorisation & restriction of chemicals).
REACH was established to control manufacturing and importing of chemicals in EU market & to minimize the risks to human health and environment.
What is a biocidal product? How can I determine if a product is a biocide or cosmetics product? What are legal obligations when it comes to biocides? What is the difference between authorization and notification of biocidal product during the transitional period?
All these questions and more are answered in this presentation. If you have more questions regarding biocides, please feel free to contact me and I will be happy to answer.
OECD Green Talks LIVE: Global eChemPortal to information on chemical substancesOECD Environment
To meet public health and environmental objectives for the safe use of chemicals under proper conditions, increasing understanding of chemical hazards and risks is key. By increasing access to data and information, governments and industry can work to reduce – or even eliminate – adverse health effects from exposures to chemicals.
The OECD eChemPortal provides direct access to critical scientific information on chemical substances of regulatory relevance with over 800,000 substance records from 37 databases. The portal allows countries and companies to share work, ensure resource efficiencies, and, subsequently, reduce animal testing.
Gerlinde Knetch (Germany), Jake Sanderson (Canada) and Violaine Verougstraete from Eurometaux shared their experience in improving chemical safety and how the eChemPortal supported this process.
The objective of this presentation is to give a briefly description of:
The legislation about the use of rubber in contact with food.
Both in US / Europe.
Implications.
Challenges for the future.
K-REACH - How to Prepare for the K-REACH LegislationCovance
In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. The two pieces of legislation introduced were the: Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 metric ton per year, requiring detailed information on their likely hazard to human health and the environment and the Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.
Are you prepared for the upcoming Substances of Concern In Products legislation requirements? We've answered all SCIP FAQ in order for you to plan ahead and plan for your compliance submissions.
Margaret Kenny, Director General, Chemicals Sector, Environment Canada and Member of the SMOC Working Group of the Commission for Environmental Cooperation spoke about Canada's Chemicals Management Plan at the Chemicals Management Forum in San Antonio, Texas, May 15, 2012. More info. at: http://www.cec.org/chemicals2012
IAEG WG1 Spring 2022_ Introduction to UK REACHraj takhar
Introduction to UK REACH presented at the International Aerospace and Environmental Group (IAEG), Working Group 1, Spring Virtual meeting, held on Wednesday 6th April 2022
What Supply Chain Managers need to do to meet effectively comply with REACH ?
By Philip Capel
LogiChem 2011 will be the event's tenth anniversary and an opportunity for the most senior chemical supply chain & global logistics directors from the European chemicals community to come together once again share experiences, make new contacts and benchmark the latest chemical supply chain initiatives.
Not only will LogiChem 2011 be a chance for the chemical industry to reminisce about the last ten years but an opportunity to shape the next decade. To celebrate a decade of LogiChem, there will be an exciting three day programme filled with networking opportunities in our new location, Antwerp.
What are new chemical substance regulations in China? And what are toxic chemical substance regulations in China? How to compliant with these regulations? What inventories can be referred? How enterprises to determine their obligations? Answers can be found in CIRS free webinar for chemical regulations & compliance in China.
This webinar will introduce current chemical management regulations in China and how to fulfill enterprises’ obligations under these regulations. Detailed operationwill be summarized here for GHS and regulatory specialist and related stake-holders to well-understand and follow up.
Presentation with Monika Srubarova from 1CC regarding the current status of ECHA SCIP, reviewing duty holder obligations, legal entities, different types of SCIP notification types, simple / complex article reporting and choosing the correct approach for data transmission (manual vs automated).
1. REACH: CORPORATE AND PRACTICE IMPACTS,
LEGISLATIVE RESPONSES
Primer on REACH
January 28, 2009
Philip A. Moffat
(202) 789-6027
pmoffat@bdlaw.com
Introduction
• New chemical regulatory scheme in the EU:
- Adopted in December 2006
- Entered in Force June 2007
• Prior to REACH, approximately 40 different
regulations and directives comprised chemical
regulatory framework in EU
• Concern about a lack of information on many
chemicals on market
2
1
2. Major REACH Provisions
• Registration (Title II)
• Data sharing (Titles III)
• Supply chain communication (Title IV)
• Downstream users (Title V)
• Evaluation (Title VI)
• Authorization (Title VII)
• Restriction (Title VIII) of
• Chemicals
3
REACH Administration
European Chemicals Agency (ECHA) is the newly
established agency responsible for managing
REACH, including registration, communication with
EU Commission, coordinating technical resources
and reviews.
Member States Competent Authorities are
responsible for enforcement, including inspections,
as well as establishment and assessment of
penalties.
• Some discretion with interpretation of requirements
• Potential for inconsistency between various Member States
• Priorities for enforcement probably risk-based (high
hazard/low exposure or lower hazard/significant exposure)
4
2
3. Exclusions from REACH
Key Exclusions:
- Radioactive substances
- Substances subject to customs supervision/free
zone that do not undergo processing and are
intended for re-exportation or are in transit
- Non-isolated intermediates
- Carriage of dangerous substances and
dangerous preparations
- Waste
5
Exemptions from Certain REACH Requirements
• REACH includes a number of exemptions for different
activities, uses, or categories of substances
• Eligibility criteria must be carefully evaluated
- Guidance available
- When in doubt, rely on regulatory text
• Selection of a particular exemption may have
consequences vis-à-vis other provisions
• Examples:
- Substances used in medicinal products
- Annex IV and V substances
- Substances in Product and Process Oriented R&D activities
- Recycled/Recovered substances
6
3
4. Key Terms
• Substance: a chemical element and its
compounds in natural state or obtained by any
manufacturing process, including any additive
necessary to preserve its stability and any
impurity deriving from the process used
• Preparation: a mixture or solution of two or
more substances
• Article: an object which during production is
given a special shape, surface or design which
determines its function to a greater extent than
does its chemical composition
7
Key Terms
• Manufacturer: any natural or legal person
established within the Community who
manufactures a substance within the
Community
- Manufacturing: production or extraction of
substances in the natural state
• Importer: any natural or legal person
established within the Community who is
responsible for import
- Import: the physical introduction into the
customs territory of the Community
8
4
5. Key Terms
• Downstream User: any natural or legal person
established within the Community, other than the
manufacturer or importer, who uses a substance,
either on its own or in a preparation, in the course of
his industrial or professional activities
- Use: any processing, formulation, consumption, storage,
keeping, treatment, filling into containers, transfer from one
container to another, mixing, production of an article or any
other utilization
• Only Representative: undefined in REACH, but
Article 8 establishes that it is a natural or legal
person established within the Community that fulfills
the role of importer for non-EU manufacturers,
formulators, or article producers
9
Registration (Title II)
• Registration ensures that persons who manufacture,
import, place on the market, or professionally use
substances have the data to evaluate and manage risks.
• EU-based Manufacturers, Importers, Only
Representatives, and certain Article Producers/Importers
have registration obligations
• 1 tonne/year threshold
• Applies to substances whether alone, in preparations, or articles
(intentionally released under normal/reasonably foreseeable use)
• Registration Types
• Full registration – most “new” and “phase-in” substances
• Light registration – certain intermediates
• “Deemed” registered – certain active substances in biocides/plant
protection products, and ELINCS substances
10
5
6. Registration (Title II)
• Registration Deadlines:
- Non-phase-in substances: June 1, 2008 or before exceeding
1 tonne threshold
- Phase-in substances: pre-registered by December 1, 2008;
otherwise full registration by June 1, 2008
• Full Registration Dossier Generally Includes:
- Technical Dossier:
• Physicochemical, Toxicological, Environmental Data (increasing
with volume)
• Classification and Labeling
• Guidance on Safe Use
• Use/Exposure
- Chemical Safety Report (for substances > 10 tonnes/year):
• Hazard/PBT Assessment
• Exposure Assessment and Risk Characterization if “Dangerous,”
PBT, vPvB
11
Registration of Phase-In Substances
• “Phase-in” substances are:
- EINECS-listed substances;
- Substances produced “within the fence line” and never placed on
the EU market after May 31, 1992; or
- No Longer Polymers.
- (On-site and transported isolated intermediates may qualify)
• 3 Phase-In Waves (over 11 years):
- Nov. 30, 2010: Highly hazardous substances (CMRs, Risk Phrase
50/53) or >1,000 tonnes/annum
- May 31, 2013: substances between 100 and 1,000 t/y
- May 31, 2018: substances in volumes between 1100 t/y
• Pre-registration (June 1 – Dec. 1, 2008) required
before registrants can benefit from Phase-In provision
12
6
7. Phase-In Substances: Joint Registration
and Data Sharing
• Multiple registrants of “same” substance must submit
one registration with:
- Agreement on Classification and Labeling
- Data on hazardous properties of substance and proposals for any
necessary testing
• Possible to opt-out and register individually
• Sharing of existing data, and joint development and
ownership of new data, through a Substance
Information Exchange Forum (SIEF) to avoid
duplicate animal testing
- SIEFs operate until 2018
- Separate consortia may also be formed
- REACH provides minimal protection for CBI – Third Party
Representatives and private arrangements contemplated in SIEF
process
13
Information in the Supply Chain (Title IV)
• Information necessary for the management of risk
associated with the use of a substance must be
communicated along the Supply Chain.
• Information to be communicated based on Chemical Safety
Assessment (CSA) when quantities exceed 10 t/y.
• Safety Data Sheet (SDS) is the primary tool for
communicating information on properties and risk
management measures for “Dangerous” and PBT / vPvB
substances.
- Exposure scenarios from CSA must be attached to SDS
• The SDS will be governed by REACH and will need to
conform with the recently enacted Globally Harmonized
System (GHS) regulation.
• Suppliers of articles with SVHCs above 0.1% (w/w) must
provide available information re safe use; name of
substance is minimum
14
7
8. Downstream Users (Title V)
• Required to consider safety of uses and apply
appropriate risk management measures
• Required to communicate with suppliers to
“identify” uses so that they are covered in any
exposure scenarios that supplier generates and
attaches to SDS
• Allowed to develop CSA and risk management
measures for uses outside of supplier’s
exposure scenario
15
EVALUATION (Title VI)
▪ The Dossier Evaluation process allows the
European Chemicals Agency (ECHA) to evaluate
testing proposals, compliance with registration
requirements and request additional data
▪ ECHA in coordination with Member States will
perform Substance Evaluation for substances
with chemical structures similar to problematic
substances, potentially resulting in requests for
additional data
▪ Data and information submitted can be used to
propose substances for Authorization (Title VII) or
Restriction (Title VIII)
16
8
9. AUTHORIZATION (Title VII)
• Substances of “Substances of Very High Concern” (SVHC):
- Carcinogenic, Mutagenic or Toxic for Reproduction (CMR 1,2)
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and
very Bioaccumulative (vPvB)
- Causing probable serious effects to human health or the environment
(e.g. Endocrine Disruptors)
• Added to “Candidate List” for possible inclusion in Annex XIV
• Once included on Annex XIV, certain uses subject to Authorization
- Persons using or making substance available must apply for
authorization within prescribed deadline seeking approval of non-
exempt uses & include an analysis of possible substitutes
• Authorization granted for a period of time, if:
- Risk adequately controlled (except non-threshold CMR, and
PBT/vPvB), or
- Socio-economic benefits outweigh risks and no suitable
alternatives
17
Restrictions (Title VIII)
▪ Restrictions may include a “Community Wide”
market ban on, or conditions on use(s) of, a
substance that poses an “unacceptable risk to
human health or the environment”:
- Proposal initiated by Member State, or European
Commission with ECHA coordination
- Evaluated in light of risk, socio-economic impact of
restriction, and availability of alternatives
▪ Many restrictions currently included in Annex
XVII, which will become effective in July 2009
- Based on currently enforceable restrictions in
Marketing Directive (76/769/EEC)
18
9