Safety & Compliance Forum

Safety & Compliance Info & Resources for
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Safety & Compliance Database






For copies of Standards, please contact the appropriate agency. PSMA does not provide copies of standards.
European Chemicals Agency (ECHA)

The European Chemicals Agency (ECHA) is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.

Locations: Europe - EU - European Union
 
Archived Events: (Click to expand/collapse)
2021-10-22
Description:

Substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHCs). If a substance is identified as an SVHC, it will be added to the Candidate List for eventual inclusion in the Authorisation List.

Participate in the consultation

Member States or the European Chemicals Agency (ECHA), on request of the European Commission, may propose a substance to be identified as an SVHC by preparing a dossier in accordance with the requirements set out in Annex XV to REACH. The Annex XV reports can be found by selecting the "Details" button in the table listing the substances that are proposed. All interested parties are invited to submit comments on such reports during the consultation.

2021-10-22
Location: European Union
2021-09-14
Description:

Around 6000 companies across the European Union have successfully complied with their new duty to notify ECHA about products containing substances of very high concern, SVHCs. The SCIP database now displays more than four million article notifications.

Based on the information submitted so far, the most commonly notified product categories in the database are:

  • machinery and their parts;
  • measuring instruments and their parts;
  • electronic equipment and their parts;
  • vehicles and their parts;
  • articles made of rubber; and
  • furniture.

The most common substances of very high concern in notifications are:

  • lead (e.g. in ball bearings, batteries);
  • lead monoxide (e.g. in lamps, vehicle parts);
  • lead titanium trioxide (e.g. in electric cookers);
  • silicid acid, lead salt (e.g. in lead crystalware, vehicle coatings); and
  • 1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15- diene, more commonly referred to as “Dechlorane PlusTM” (e.g. in paints, glues)

You can search the data by article name or brand, product category, type of material or the chemical name. The data will help consumers make informed choices by checking whether a product contains hazardous chemicals and reading its safe use instructions. Waste operators can use the data to increase the re-use of articles and further develop recycling processes. 

ECHA’s Executive Director, Bjorn Hansen says: “Today’s launch improves access to information on hazardous chemicals in articles on the EU market. It will help to track products containing substances of very high concern until they reach the waste stage, supporting the goals of a circular economy. We encourage everyone to get familiar with the database and use it.”

Virginijus Sinkevičius, EU Commissioner for Environment, Oceans and Fisheries, says:

“The launch of the database is a true milestone in bringing transparency about chemicals of concern in products. This wealth of information will be of great value to all, especially consumers, waste operators, and policy-makers. It will enhance the delivery of safe and clean products and secondary materials, fully in line with the priorities on re-use and recycling defined in the EU waste legislation. Thanks to all the companies that promptly submitted information, making the database work. This is a key step in implementing deliverables of the European Green Deal, notably our action plans on circular economy and zero pollution, and our Chemicals Strategy for Sustainability.”

All companies placing articles containing substances of very high concern on the EU market have to notify them to the database. To help companies with this duty, ECHA has developed several guidance documents and tools.

Background

Companies supplying articles that contain substances of very high concern, SVHCs, on the REACH Candidate List have to notify these to ECHA. The requirement concerns articles on the EU market that contain more than 0.1 % weight by weight of SVHCs. The obligation came into force on 5 January 2021 and is based on the EU Waste Framework Directive as revised in 2018.

The notifications are stored in the Substances of Concern in Products (SCIP) database, which ensures that the information is publicly available throughout the whole lifecycle of products and materials, including the waste stage.

SCIP provides all the technical data from companies allowing the safe use and improved re-use and recycling of the article. This includes: information to identify the article, instructions on how to use it safely, the substance of very high concern, its location, and the type of material in which it is contained.

At the moment, the database contains over four million article notifications. This number counts duplicate notifications for the same article that were made by several actors in the EU supply chains, as well as notifications made for more than one article. Therefore, ECHA does not have an estimation for the exact number of different articles in the database.

2020-02-07
Description:

REACH: Four New Substances Listed as SVHC

On 16 January 2020, the European Chemicals Agency (ECHA) announced four new substances will be viewed as Substance of Very High Concern (SVHC) and have been added to the Candidate List under REACH regulation (EC) 1907/2006.

The ECHA Candidate List now contains 205 substances.

Background

After inviting interested parties to comment on the addition of four potential new SVHCs, the Member States Committee agreed on including the four potential substances to the ECHA Candidate List. Therefore the list now contains 205 substances in total.

Once a substance is put on the Candidate List, producers, importers or suppliers may have information obligations if the article contains more than 0.1% of an SVHC. Notification of the ECHA is required as well if the total amount of the specific SVHC exceeds 1 ton/ year.

 

The Four New SVHCs: Name

CAS no. (EC no.)

Reason for Inclusion

Potential Uses

Diisohexyl phthalate

71850-09-4

(276-090-2)

Toxic for reproduction (Article 57c)

Not registered under REACH. According to the Annex XV dossier, it is also used as sealant and plasticiser in polymers.

2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone

119313-12-1

(404-360-3)

Toxic for reproduction (Article 57c)

The substance is used in polymer production. It also used in surface coatings and ink.

2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one

71868-10-5

(400-600-6)

Toxic for reproduction (Article 57c)

The substance is used in polymer production. It also used in coatings, adhesives and inks.

Perfluorobutane sulfonic acid (PFBS) and its salts

-

(-)

Equivalent level of concern having probable serious effects to the environment and human health (Article 57(f) – environment & human health)

Used as a catalyst/ additive/reactant in polymer manufacture and in chemical synthesis. It is also used as a flame retardant in polycarbonate (for electronic equipment). It is also used in metal (chromium) plating, water and stain repellent protection for leather, textiles and carpets.

2017-04-05
Location: Finland
Description:

Follow our Stakeholders' Day live

Follow our Stakeholders’ Day live to get the latest news and advice on the REACH 2018 registration deadline. The programme features updates and advice from ECHA and industry on three topics: REACH 2018 - one year to go, case studies for successful registration and using chemicals safer in Europe.

Follow our Stakeholders' Day live


ECHA

Help us improve our news products

Now’s your chance to help us improve our news products. Last week, you received an email with a link to our news readership survey. We also sent a reminder on Monday. The survey should only take 10 minutes to complete, so if you haven’t given us your views yet, let us know what you think.

If you subscribe to our news, but have not yet received the link, let us know at: surveys@echa.europa.eu.

The survey will be open until 14 April 2017.


REACH

Newcomer to the market? Act by 31 May to get one more year to prepare your registration

To benefit from the 31 May 2018 registration deadline for low volume, existing substances, you need to have pre-registered them. You can still do so if you have recently entered the European market. The last chance is on 31 May 2017. If you do not pre-register by that date, you will need to register your substance before you can manufacture or import it.

News alert | Pre-registration

Lead registrant list updated

ECHA has recently updated the list of substances for which a lead registrant has been declared in REACH-IT. It now includes over 10 000 substances that have a joint submission and are either already registered or going to be registered for the REACH 2018 deadline.

List of lead registrants

Update to REACH 2018 statistics – 8 500 registrations submitted for the last deadline

The statistics about the registrations for the May 2018 deadline have been updated. 8 547 registrations have been submitted for 4 257 substances.

Registration statistics 2018 | Overall registrations

OECD QSAR Toolbox update simplifies the correct use of non-test methods

The update introduces two new features. Fully automated predictions can be ran for skin sensitisation and short-term toxicity to fish. The standardised workflow, on the other hand, proposes the best options for the endpoints and lets the expert choose among them. With the update, filling data gaps for REACH registration is possible even for scientists with no or little experience with the software.

News item | QSAR Toolbox download and support

Forum elects new chairs and starts to work with BPR subgroup

The Forum has elected its new chairs and the Forum’s BPR subgroup met for the first time to decide on a project on the control of classification and labelling of biocidal products.

News item | Enforcement Forum

Committees’ opinions on applications for authorisation available

The consolidated opinions of the Committees for Risk Assessment and Socio-economic Analysis are available on our website for:

  • one use of arsenic acid (EC 231-901-9; CAS 7778-39-4) by CIRCUIT FOIL LUXEMBOURG SARL;
  • one use each of chromium trioxide (EC 215-607-8; CAS 1333-82-0) by CIRCUIT FOIL LUXEMBOURG SARL, and Gerhardi Kunststofftechnik GmbH as the submitting applicant and 11 co-applicants; and
  • two uses of formaldehyde, oligomeric reaction products with aniline (EC 500-036-1; CAS 25214-70-4) by Polynt Composites France.

Adopted opinions


CLP

New intention to harmonise classification and labelling

A new intention to harmonise the classification and labelling has been received for tris(2-methoxyethoxy)vinylsilane (EC 213-934-0, CAS 1067-53-4).

CLH intentions | Submitted CLH proposals


Poison centres

New CLP annex harmonises information relating to emergency health response

On 22 March 2017, the Commission Regulation (EU) 2017/542 was published in the Official Journal. This amends the CLP Regulation by adding Annex VIII, which harmonises information relating to emergency health response and preventative measures across all Member States.

Official Journal | Poison centres


Biocides

How to calculate environmental emissions of preservatives?

More help is available to estimate the release of substances from biocidal products to the environment. You can now download calculation sheets for preservatives: film preservatives (product-type 7); fibre, leather, rubber and polymerised materials preservatives (for leather) (product-type 9); and paper coating and finishing (product-types 6, 7 and 9). Get the Excel files from our website, under "Emission scenario documents". You now have access to calculation sheets for 13 different product-types.

Emission scenario documents | Background


Board of Appeal

Decision on a data sharing dispute published

Case A-001-2016 concerns a decision on a data sharing dispute under the Biocidal Products Regulation. The Board of Appeal dismissed the appeal and found that the Agency did not commit an error in its assessment of the efforts of the parties to that dispute. However, by characterising a cost calculation method as unfair, the Agency exceeded its powers.

Decision


Guidance

New drafts for REACH guidance updates available

New drafts for updated ECHA guidance on REACH have been sent for the next consultation step:

  • Guidance on Information Requirements and Chemical Safety Assessment – Chapters R.11, R.7b, R.7c and Part C, related to PBT/vPvB assessment, sent for CARACAL consultation.

Copies of the new drafts have been uploaded to the ongoing guidance consultations page on our website.

Potential registrants for the 2018 deadline may be interested in already viewing the new draft documents.

Ongoing guidance consultations

Updated Guidance in a Nutshell on substance identification published in 23 languages

The updated Guidance in a Nutshell on identification and naming of substances under REACH and CLP (version 2.0) has been translated and is now available in 23 languages on our website.

Guidance in a Nutshell on identification and naming of substances under REACH and CLP


Events

Seminar on 10 years of REACH Litigation

Welcome to Helsinki on Wednesday 24 May 2017 for our REACH Litigation Seminar on the occasion of REACH’s 10-year anniversary. This one-day seminar is aimed at lawyers and is organised jointly by ECHA and the Board of Appeal of ECHA. The seminar will discuss the similarities and differences in the European Courts’ and the Board of Appeal’s work on REACH over the past 10 years, mainly from the angle of procedure and scope of review.

Event page

Did you miss our webinar on sector use maps?
30 March, 11:00 to 13:00 Helsinki time (EET)

Almost 250 people followed our webinar last week: how sector use maps support the generation of more meaningful exposure scenarios. The large majority of participants were satisfied or very satisfied with the event. If you were not able to join or would like to see parts again, don't worry, the recording and presentations are available on our website.

We will publish a summary of the webinar questions and answers in the coming weeks.

Event page


Calls for information

Public consultation on harmonised classification and labelling

ECHA is looking for comments on the harmonised classification and labelling proposals for:

  • granulated copper (EC 231-159-6; CAS 7440-50-8). It is an approved active substance used in biocidal products for wood preservation with no existing harmonised classification and labelling in Annex VI to CLP. We invite you to provide comments on all hazard classes (physical, human health and environment hazard classes), except respiratory sensitisation, aspiration hazard and hazardous to the ozone layer.
  • ethofumesate (ISO) (±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate (EC 247-525-3; CAS 26225-79-6). It is a herbicide used as an active substance in plant protection products with an existing harmonised classification and labelling in Annex VI to CLP. Comments on hazards to the aquatic environment are invited.
  • 1,2-benzenedicarboxylic acid, di-C8-10-branched alkylesters, C9-rich; [1] di-“isononyl” phthalate; [2] (EC 271-090-9 and 249-079-5; CAS 68515-48-0 and 28553-12-0). The substance is an industrial chemical used mainly as a plasticiser in PVC with no existing harmonised classification and labelling in Annex VI to CLP. We invite you to provide comments on the reproductive toxicity hazard class.

The deadline for comments is 19 May 2017, 23:59 Helsinki time (EET).

Give comments

Additional public consultation on harmonised classification and labelling

ECHA launches an additional public consultation on the proposal to harmonise the classification and labelling of ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivatives (EC 308-208-6, CAS 97925-95-6). The initial public consultation ended on 16 January 2017. Due to a technical problem, Annex I to the report, containing detailed study summaries as a basis of the CLH proposal, was not available during the public consultation. For this reason, an additional public consultation is now open for the reproductive toxicity hazard class.

The deadline for comments is 25 April 2017, 23:59 Helsinki time (EET).

Give comments | Previous public consultation

Have a look at the 51 currently open consultations on our home page.

All open consultations

419 days until the REACH 2018 deadline

ECHA

REACH-IT closed for Easter
14 April to 18 April
10:00 (Helsinki time)

REACH-IT closed for maintenance
20 April 14:00 to 25 April 10:00 (Helsinki time)

Vacancies

ECHA is looking for legal advisors

Traineeship open positions

Events

Biocides Stakeholders' Day
26-27 September 2017

Upcoming events

REACH 2018 events

Webinars

Completeness check - preparing a registration dossier that can be successfully submitted to ECHA
20 April 2017

Getting your chemical safety assessment done
17 May 2017

REACH 2018 Spring School
15-19 May 2017

More webinars

Consultations

Check all 51 currently open consultations on our home page or subscribe to our RSS feed to stay up-to-date

Quick links

Authorisation List

Candidate List

Getting started

Substances of potential concern

Use maps library

Support

Terminology

ECHA Weekly archive

 

 

 

2017-03-28
Location: Finland
Description:

Data on 15 000 chemicals now available to use

Key information on around 15 000 chemicals can now be downloaded and used. Researchers, regulatory authorities and businesses can use it – not least to improve the safe use of chemicals, enable innovation and help avoid unnecessary testing of chemicals on animals.

Press release | REACH study results

ECHA

Forum elects new Chair and Vice Chairs

The Enforcement Forum has elected Ms Katja vom Hofe (Germany) as its new Chair. Ms Sinead McMickan (Ireland) and Ms Szilvia Deim (Hungary) have been elected as the Forum's new Vice Chairs.

Enforcement Forum

What do you think of our news products?

Now’s your chance to help us improve our news products. On Monday, you received an email with a link to our news readership survey. The survey should only take 10 minutes to complete, so if you haven’t given us your views yet, let us know what you think of our ECHA Weekly and our ECHA Newsletter.

If you subscribe to our news, but have not yet received the link, let us know at: surveys@echa.europa.eu.

The survey will be open until 14 April 2017.

REACH-IT update at the end of April – downtime before

Our dossier submission tool, REACH-IT, will be updated on 25 April. The update will focus mainly on increasing the capacity of the system to handle the large number of dossiers expected for the 2018 deadline. It also includes a new submission type for the alternative chemical name requests under the CLP Regulation.

To manage the update, we will close REACH-IT from Thursday 20 April at 14.00 (EET) to Tuesday 25 April at 10.00 (EET). Regulatory deadlines that may affect companies during the closing period (e.g. completeness check deadlines) will be moved to 25 April.

Similarly, any completeness check deadlines falling during the Easter closure, 14 April to 17 April, will be moved to the 18 April.

ECHA advices registrants to pay attention to their messages in REACH-IT in the days before the closure, in particular those that are undergoing a dossier evaluation or substance evaluation assessment.

The last major update of REACH-IT before the 2018 deadline is expected to be in October 2017.

IUCLID 5 website closing

The IUCLID 5 website will be shut down permanently from 30 March 2017 onwards. All relevant content has been transferred to the IUCLID 6 website. If you still use the IUCLID 5 website, download any information you may need, e.g. a copy of your legal entities, before Thursday. From Thursday onwards, the IUCLID 6 website is the only source for IUCLID news and support.

News

REACH

Registrants should get ready to comment on 2016 substance evaluation draft decisions

ECHA will soon send information requests on 27 substances to registrants for comments. These substances were evaluated by the Member States in 2016.

News alert | CoRAP list of substances

New proposals and intentions to harmonise classification and labelling

Proposals have been received for:

  • 2-butoxyethanol (EC EC 203-905-0; CAS 11-76-2);
  • theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione (EC 200-385-7; CAS 58-55-9);
  • tribenuron-methyl (ISO); methyl 2-[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-N-methylcarbamoylsulfamoyl]benzoate (EC 401-190-1; CAS 101200-48-0);
  • trimethoxy(methyl)silane (EC 214-685-0; CAS 1185-55-3).

A new intention to harmonise the classification and labelling has also been received for phosphine (CAS 232-260-8; CAS 7803-51-2).

Submitted CLH proposals | CLH intentions

Committees’ opinion on application for authorisation available

The consolidated opinion of the Committees for Risk Assessment and Socio-economic Analysis for a use of bis(2-methoxyethyl) ether (Diglyme) (EC 203-924-4; CAS 111-96-6) by MAFLON S.P.A. is available on our website.

Adopted opinions

Downstream users

Supply chain communication tools

Our new interactive infographic gives information about a range of tools designed to improve communication in the supply chain between between suppliers and users of chemicals.

Communication in the supply chain

Guidance

Translations of guidance documents now available

The following guidance documents are now available in 23 languages on our website:

  • updated Guidance in a nutshell on data-sharing (version 2.0) published in February 2017; and
  • updated Guidance for identification and naming of substances under REACH and CLP (version 2.0) published in December 2016.

Guidance in a nutshell on data-sharing | Guidance for identification and naming of substances under REACH and CLP

Events

Get our REACH 2018 advice live next week

Our Stakeholders’ Day will be streamed live on 4 and 5 April. Get advice from ECHA and industry on the REACH 2018 registration deadline and follow training on the IT tools. The event also features best practice for ensuring the safe use of chemicals in the supply chain. Send us your questions and feedback online.

Programme

Last chance to register: getting meaningful exposure scenarios: how sector use maps help
30 March, 11:00 to 13:00 Helsinki time (EET)

Participants will learn about the sector use map concept, its benefits, and its implementation.

This webinar is of interest for downstream users and their sector organisations who want to optimise the communication of safe use information in the supply chain.

Event information and registration

Calls for information

There are no new consultations this week. Have a look at the 47 currently open consultations on our home page.

All open consultations

 

 

 

 

 

2017-03-22
Location: Finland
Description:

Member States to evaluate 22 substances in 2017

ECHA has adopted the updated Community rolling action plan (CoRAP) which starts the evaluation for the 22 substances listed for 2017. Registrants of the listed substances are encouraged to coordinate their actions and contact the evaluating Member States.

News alert | CoRAP 2017-2019 list [PDF]

REACH

Update to the list of substances potentially subject for compliance checks

ECHA has updated the list of substances that might be chosen for compliance checks. The list includes 130 new substances. Registrants are advised to check this list and, if needed, update their related registration dossiers and registration tonnage bands by 22 May 2017.

Since January 2015, ECHA has published a list of substances for which a compliance check would in all probability be conducted. This gives the registrants the possibility for early dossier updates before the compliance check starts. However, the list is indicative and non-exhaustive: ECHA reserves the right to open further compliance checks on any dossier at any time and without prior notice to registrants.

Substances potentially subject to compliance checks | Compliance checks

Restriction proposal on four phthalates and several authorisation applications agreed by RAC and SEAC

The Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) agreed on a restriction proposal on four phthalates (DEHP, DBP, DIBP and BBP) in articles and on TDFA in sprays used by the general public. The committees also agreed on 19 draft opinions and adopted three final opinions on applications for authorisation.

News alert | Annex

New intention to restrict substances

New intention has been received on 13 March to restrict the manufacturing, placing on the market, industrial and professional use of following substances including their salts and precursors:

  • perfluorononan-1-oic acid (PFNA) (EC206-801-3; CAS 375-95-1);
  • nonadecafluorodecanoic acid (PFDA) (EC 206-400-3; CAS 335-76-2);
  • henicosafluoroundecanoic acid (PFUnDA) (EC 218-165-4; CAS 2058-94-8);
  • tricosafluorododecanoic acid (PFDoDA) (EC 206-203-2; CAS 307-55-1);
  • pentacosafluorotridecanoic acid (PFTrDA) (EC 276-745-2; CAS 72629-94-8);
  • heptacosafluorotetradecanoic acid (PFTDA) (EC 206-803-4; CAS 376-06-7).

The expected submission date is 14 July 2017.

Current Restriction intentions

Committees’ opinions on applications for authorisation available

The consolidated opinions of the Committees for Risk Assessment and Socio-economic Analysis for several uses of the following substances by Gentrochema BV are available on our website:

  • two uses of potassium dichromate (EC 231-906-6; CAS 7778-50-9);
  • three uses of sodium dichromate (EC 234-190-3; CAS 7789-12-0, 10588-01-9).

Adopted opinions

Downstream users

Getting meaningful exposure scenarios: how sector use maps help - sign in for the webinar

The webinar taking place on 30 March is of interest for downstream users and sector organisations who want to optimise the communication of safe use information in the supply chain. Participants will learn about the sector use map concept, its benefits, and its implementation.

Register

Events

REACH 2018 and beyond
27-28 April 2017, Sofia, Bulgaria

Do you know your obligations under REACH? Need help in preparing for the 2018 registration deadline? The European Commission organises this event to highlight the companies’, especially SMEs', obligations under REACH. You will also be able to get help on your preparations for the upcoming 2018 registration deadline. Register now and book your one-to-one session with a REACH expert to get tailor-made advice. Participation is free of charge.

Event information and registration

ECHA webinar: completeness check - preparing a registration dossier that can be successfully submitted to ECHA
20 April 2017, 11:00 to 12:00 Helsinki time (EET)

This webinar is relevant for any company preparing a REACH registration dossier. It focuses on experience gained since the revised completeness check was introduced in June 2016. You will also get valuable insight into the manual checks performed by ECHA staff as part of the completeness check.

Registration

Calls for information

Public consultation on proposals to restrict lead compounds in PVC and diisocyanates launched

ECHA has submitted a report proposing a restriction on the placing on the market of PVC articles containing lead compounds as stabilisers in concentrations greater than 0.1% by weight. Time limited derogations are foreseen for articles produced from recycled PVC and for PVC silica separators used in lead acid batteries. In addition, PVC articles covered by EU-specific legislation that regulates lead (food contact materials; electric and electronic devices, packaging and toys) as well as second-hand articles are exempted from the proposed restriction.

Germany has resubmitted the proposal to restrict diisocyanates for industrial and professional uses, following the nonconformity of the original submission.

The consultations are open from 22 March 2017 to 22 September 2017. ECHA’s scientific committees welcome early comments by 1 June to help them in the first discussion of the proposal in September 2017.

Submitted restrictions under consideration

Public consultations on SEAC's draft opinions on restrictions

ECHA is looking for comments on the draft opinions of the Committee for Socio-economic Analysis (SEAC) concerning the following two restriction proposals:

  • Bis(2-ethylhexyl) phthalate (DEHP) (EC 204-211-0; CAS 117-81-7); Benzyl butyl phthalate (BBP) (EC 201-622-7; CAS 85-68-7); Dibutyl phthalate (DBP) (EC 201-557-4; CAS 84-74-2) and Diisobutyl phthalate (DIBP) (EC 201-553-2; CAS 84-69-5) in articles submitted by ECHA and Denmark;
  • TDFAs (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silanetriol and any of its mono-, di- or tri-O-(alkyl) derivatives (EC -, CAS -) in spray products submitted by Denmark.

The deadline for comments is 22 May 2017.

Give comments

Have a look at the 50 currently open consultations on our home page.

All open consultations

 

 

 

 

2017-03-15
Location: Finland
Description:

Glyphosate not classified as a carcinogen by ECHA

ECHA's Committee for Risk Assessment (RAC) agrees to maintain the current harmonised classification of glyphosate as a substance causing serious eye damage and being toxic to aquatic life with long-lasting effects. RAC concluded that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction.

Press release

REACH

Commission grants authorisation for 1,2-dichloroethane (EDC)

The European Commission has granted an authorisation to Laboratoires Expanscience, for the use of 1,2-dichloroethane (EDC) (EC 203-458-1; CAS 107-06-2) as a process and extracting solvent in the manufacture of plant-derived pharmaceutical bioactive ingredients.
The review period for the authorisations will expire on 22 November 2029.

Commission decision

Reminder: Last call to pre-register your chemicals

To benefit from the extended deadline for registering existing, low volume chemicals by the last REACH registration deadline, you need to have pre-registered your substance with ECHA. If you manufacture or import a substance for the first time at or above 1 to 100 tonnes per year, and your substance is not known to be carcinogenic, mutagenic or toxic to reproduction, you can still pre-register within six months of starting the activity, and at the latest by 31 May 2017 – one year before the deadline.

News alert

Investigation report on formaldehyde and formaldehyde releasers published

At the request of the European Commission, ECHA has prepared an investigation report on formaldehyde and formaldehyde releasers.

ECHA identified several formaldehyde releasers and potential ones that would be subject to REACH and clarified their uses.

The report aims to assist the Commission in their consideration of whether or not to request ECHA to prepare an Annex XV restriction dossier.

Read the report

CLP

New proposals and intentions to harmonise classification and labelling

Six new proposals to harmonise classification and labelling have been received for:

  • α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (EC 269-855-7, CAS 68359-37-5)
  • Margosa Ext. [from the Kernels of Azadirachta Indica Extracted With Water and Further Processed With Organic Solvents] (EC 283-644-7, CAS 84696-25-3)
  • Dichlorodioctyl stannane (EC 222-583-2, CAS 3542-36-7)
  • Mesotrione (ISO); 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione (CAS 104206-82-8)
  • Dioctyltin dilaurate; bis(dodecanoyloxy)(dioctyl)stannane (EC 222-883-3, CAS 3648-18-8)
  • 2,2-dibromo-2-cyanoacetamide (EC 233-539-7, CAS 10222-01-2)

Two new intentions to harmonise the classification and labelling have been received for:

  • N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane (CAS 874967-67-6); and
  • 4-methylpentan-2-one (EC 203-550-1, CAS 108-10-1)

Submitted CLH proposals | Current CLH intentions

Guidance

New draft for REACH guidance update available

A new draft for updated ECHA guidance on REACH has been sent for the next consultation step:

  • Guidance on Information Requirements and Chemical Safety Assessment – Chapter R.7a, Section R.7.5 (related to repeated dose toxicity) sent for RAC and MSC consultation

The new draft has been uploaded to the ongoing guidance consultations page on our website.

Potential registrants for the 2018 deadline may be interested in already viewing the new draft document.

Ongoing guidance consultations

Downstream users

Interactive guide on safety data sheets and exposure scenarios translated

You can now enjoy reading and using the guide in your own language. The guide helps suppliers and recipients of safety data sheets compile and understand substance and use information.

Interactive guide

Events

REACH 2018 and beyond
27-28 April 2017, Sofia, Bulgaria

Do you know your obligations under REACH? Need help in preparing for the 2018 registration deadline? The European Commission organises this event to highlight the companies', especially SMEs', obligations under REACH. You will also be able to get help on your preparations for the upcoming 2018 registration deadline. Register now and book your one-to-one session with a REACH expert to get tailor-made advice. Participation is free of charge.

Event information and registration

ECHA webinar: completeness check - preparing a registration dossier that can be successfully submitted to ECHA
20 April 2017, 11:00 to 12:00 Helsinki time (EET)

This webinar is relevant for any company preparing a REACH registration dossier. It focuses on experience gained since the revised completeness check was introduced in June 2016. You will also get valuable insight into the manual checks performed by ECHA staff as part of the completeness check.

Registration

Calls for information

Two proposals to identify new substances of very high concern

The substances and examples of their uses are:

  • 4,4'-isopropylidenediphenol (Bisphenol-A) (EC 201-245-8). Used in the manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing PVC and in thermal paper production.
  • Perfluorohexane-1-sulphonic acid and its salts (EC 206-587-1). Not yet registered under REACH, but may be used as a plasticiser, lubricant, surfactant, wetting agent, corrosion inhibitor and in fire-fighting foams. Belongs to the group of perfluoroalkyl sulfonic acids (PFSAs).

The deadline for comments is 24 April 2017.

SVHC identification

Consultation on substances for harmonised classification and labelling

ECHA is seeking comments on harmonised classification and labelling proposals for eight substances:

  • Diisooctyl phthalate (EC 248-523-5; CAS 27554-26-3)
  • silicon carbide (fibres fulfilling the WHO definition: diameter < 3 µm, length > 5 µm and aspect ratio ≥ 3:1) (EC -; CAS -)
  • Margosa, ext. [cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide] (EC 283-644-7; CAS 84696-25-3)
  • Branched hexatriacontane (EC 417-070-7; CAS 151006-62-1)
  • Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol (CAS No 125225-28-7, all stereoisomers; 115850-69-6, cis-cis(cc)racemate; 115937-89-8, cist-trans (ct)racemate)
  • L-(+)-lactic acid; (2S)-2-hydroxypropanoic acid (EC 201-196-2; CAS 79-33-4)
  • 2-methoxyethyl acrylate (EC 221-499-3; CAS 3121-61-7)
  • Imiprothrin (EC 428-790-6; CAS 72963-72-5)

Comments should be submitted by 28 April 2017, 23:59 Helsinki time (EET).

News item | Give comments

Have a look at the 46 currently open consultations on our home page.

All open consultations

 

2017-03-08
Location: Finland
Description:

Public consultation on seven substances proposed for authorisation under REACH

ECHA is looking for comments on its proposal to include seven new substances in the REACH Authorisation List. The deadline for comments is 2 June 2017.

Press release | Annex

ECHA

Reply to NGOs on the independence and transparency of ECHA’s Risk Assessment Committee

ECHA’s letter assures the impartiality of the impending decision on glyphosate.

News item


REACH

How to consider a read-across approach for multi-constituent and UVCB substances

A new document on using read-across for multi-constituent and unknown or variable composition, complex reaction products or biological materials (UVCB) substances describes key issues for assessing and addressing the complexity of read-across approaches for these substances. Furthermore, it contains example model cases to illustrate this complexity.

News item | Document

Commission processing reproductive toxicity decisions

The European Commission is processing draft implementing decisions requesting registrants to update their dossiers with information relating to the extended one-generation reproductive toxicity study (EOGRTS).

ECHA had referred these cases to the Commission as a unanimous agreement on them was not reached in the Member State Committee. The public versions of the final Commission decisions will be published later on DG Environment’s and ECHA’s web pages.

EOGRTS has been the information requirement for reproductive toxicity in REACH since March 2015.

Read more | Guidance on information requirements and chemical safety assessment - chapter R.7a

REACH registrants survey - best practice in updating dossiers

ECHA will conduct a study to examine the challenges and incentives for updating dossiers and to identify best practice that could help companies improve their data. This is done as part of ECHA’s efforts to maximise the availability of high quality data to enable the safe manufacture and use of chemicals.

A survey will be sent to a large number of registrants at the end of March. If your company is among them, please share your experiences with us.

Further substances assessed by authorities

The public activities coordination tool (PACT) has been updated with information on 12 substances that are undergoing risk management option analysis or hazard assessment by authorities.

Public activities coordination tool

Committees’ opinions on applications for authorisation available

The consolidated opinions of the Committees for Risk Assessment and Socio-economic Analysis for the following substances are available on our website:

  • two uses of chromium trioxide (EC 215-607-8; CAS 1333-82-0) by MTU Aero Engines AG;
  • bis(2-methoxyethyl) ether (EC 203-924-4; CAS 111-96-6) by Merck KGaA.

Opinions


CLP

New procedure for alternative chemical name requests

An updated version of REACH-IT will be released by the end of April 2017. After the release, all alternative chemical name request dossiers (Article 24 of CLP), including updated dossiers requested by ECHA, must be submitted using REACH-IT. To support the transition of dossier submissions into the updated REACH-IT, the webform for alternative chemical name requests will be open until mid-April. After this time, you will no longer be able to use the webform. Please consider this if you plan to submit alternative chemical name request dossiers. The exact dates for the transition will be communicated on ECHA’s website in April.


Biocides

Biocidal Products Committee adopts six opinions

The Biocidal Products Committee (BPC) has adopted opinions supporting the approval of three active substances for use in biocidal products used as preservatives and repellents and one opinion on the comparative assessment for anticoagulant rodenticides. One additional opinion is expected to be adopted by written procedure.

News alert


Board of Appeal

Board of Appeal decision in an appeal concerning the registration requirements for nanoforms published

The Board of Appeal has published its decision in Case A-011-2014, which concerns a dossier evaluation for titanium dioxide. The dossier evaluation considered the substance identity information required only and not the information requirements for human health and environmental effects. The contested decision requested detailed substance identity information on the crystal phases, nanoforms and surface treatment of nanoforms covered by a registration. The Board of Appeal annulled the contested decision.

Decision | Summary


Downstream users

Do you use an authorised substance?

The Commission has recently granted an authorisation to Chimcomplex S.A. Borzesti for the industrial use of trichloroethylene (EC 201-167-4; CAS 79-01-6) as a solvent and as a degreasing agent in closed systems. The authorisation number is REACH/16/9/0.

If Chimcomplex S.A. Borzesti is your immediate or further upstream supplier for this substance, the authorisation number should be included in the safety data sheet (SDS) they provide.

If you do not have your own authorisation for your use, you have to comply with the conditions of the authorisation described in the SDS. You need to notify your use to ECHA within three months of the first time the substance was delivered to you after the authorisation decision was published in the Official Journal (15 February 2017).

As described in this authorisation decision, you also need to provide occupational exposure data to ECHA. We will forward this data to the authorisation holder, who will use it to prepare a potential review report by 21 August 2017.

Notify ECHA for authorised uses | Decision


Events

ECHA webinar: Getting meaningful exposure scenarios: how sector use maps help
30 March 2017

This webinar is of interest for downstream users and sector organisations who want to optimise the communication of safe use information in the supply chain. Participants will learn about the sector use map concept, its benefits, and its implementation.

Register

Final call: get the latest on REACH 2018

Four weeks to go to our Stakeholders’ Day on 4 and 5 April. There are still some places left – register today for the most up-to-date advice and case studies to help you register. You can also get training on IT tools and book a one-to-one discussion with our experts - when possible, we will offer you this service in your language.

Event page

ECHA webinar: REACH 2018 spring school: from zero to registration in one week
15-19 May 2017

During this intensive week, we will broadcast all the REACH 2018 phase webinars again with the possibility of asking questions from our experts. In addition, a new webinar: Getting your chemical safety assessment done will take place live from Helsinki on Day 3 of the spring school, Wednesday 17 May. The week will conclude with an extended Q&A on all REACH 2018 phases on Friday 19 May. This is your chance to get expert advice to your specific questions so register now to ensure your place!

Register


Calls for information

Have a look at the 24 currently open consultations on our home page.

 

 

 

 

2017-03-01
Location: Finland
Description:

Important safety information on chemicals still missing

Substances of potential concern were targeted by ECHA’s compliance checks in 2016. Most of the evaluated registration dossiers had data gaps and need updating. The annual evaluation report covers evaluation activities and other measures to improve data quality. It also has recommendations for registrants.

Press release | Evaluation report 2016

REACH

Recycled rubber infill causes a very low level of concern

ECHA has evaluated the risk of substances in recycled rubber that is used on artificial sports pitches. Based on the evidence, ECHA has concluded that the concern for players on these pitches, including children, and for workers who install and maintain them is very low. ECHA will update its evaluation as and when new information becomes available.

Press release | Report

Reminder: Last call to pre-register your chemicals

To benefit from the extended deadline for registering existing, low volume chemicals by the last REACH registration deadline, you need to have pre-registered your substance with ECHA. If you manufacture or import a substance for the first time at or above 1 to 100 tonnes per year, and your substance is not known to be carcinogenic, mutagenic or toxic to reproduction, you can still pre-register within six months of starting the activity, and at the latest by 31 May 2017 – one year before the deadline.

News alert

Check the upcoming events on REACH 2018 registration

Together with our stakeholders, we have put together a calendar of events around Europe focusing on support for the last registration deadline. Check it out - there might be an event perfect for you just around the corner.

REACH 2018 events

E-cards sent to 2018 pre-registrants

In mid-January, we sent out electronic cards through email to around 18 000 pre-registrants with no prior registrations, lead registrants and members of joint submissions reminding them of the 31 May 2018 deadline. The cards are now also available online.

Web page

Statistics published about downstream notifications for authorised uses of substances of very high concern

Companies using authorised substances of very high concern need to notify ECHA. The notification requirement is based on Article 66 of the REACH Regulation. ECHA passes on the notifications to the enforcement authorities of the EU Member States. A table and maps indicating the number and geographical distribution of the notifications received have now been published by ECHA.

Read more

Committees’ opinions on two applications for authorisation available

The consolidated opinions of the Committees for Risk Assessment and Socio-economic Analysis for uses of the following substances are available on our website:

  • chromium trioxide (EC 215-607-8; CAS 1333-82-0) by SNECMA;
  • 1,2-dichloroethane (EDC) (EC 203-458-1, CAS 107-06-2) by Eli Lilly S.A.

Opinions


Board of Appeal

Revised practice directions give guidance to appellants

The Board of Appeal has adopted revised practice directions to guide parties involved in appeal proceedings.

News alert


Guidance

New Biocides Guidance document published

ECHA has published a new Guidance document for the Biocidal Products Regulation (BPR), concerning the efficacy assessment and evaluation for biocidal active substances and products.

Guidance on biocides legislation

New draft for REACH guidance update available

The following new draft for updated ECHA guidance on REACH has been sent for the next consultation step:

  • Guidance on recommendations for nanomaterials for human health endpoints sent for CARACAL consultation.

A copy of the new draft has been uploaded to the ongoing guidance consultations page on the ECHA website. Potential registrants for the 2018 deadline may be interested in already viewing the new draft document.

Ongoing guidance consultations


Events

ECHA webinar: Getting meaningful exposure scenarios: how sector use maps help
30 March 2017

This webinar is of interest for downstream users and sector organisations who want to optimise the communication of safe use information in the supply chain. Participants will learn about the sector use map concept, its benefits, and its implementation.

Register

Impacted by REACH? Join our Stakeholders' Day

One year until the REACH 2018 registration deadline, our conference on 4 and 5 April offers you the most up-to-date advice and case studies to help you register.

On 4 April, you can take part in training and book a one-to-one discussion with our experts - when possible, we will offer you this service in your language. Check the programme and sign up today. You will also be able to watch the event and ask questions online.

Event page

ECHA webinar: REACH 2018 spring school: from zero to registration in one week
15-19 May 2017

During this intensive week, we will broadcast all the REACH 2018 phase webinars again with the possibility of asking questions from our experts. In addition, a new webinar: Getting your chemical safety assessment done will take place live from Helsinki on Day 3 of the spring school, Wednesday 17 May. The week will conclude with an extended Q&A on all REACH 2018 phases on Friday 19 May. This is your chance to get expert advice to your specific questions so register now to ensure your place!

Register

ECHA webinar: Replacing harmful chemicals in the textile sector: presentations and recording available
23 February 2017

The webinar presents how H&M and a group of Italian SMEs from the Prato district replaced harmful chemicals from their supply chains. Greenpeace presents their Detox campaign, the International Chemical Secretariat (ChemSec) gives an overview of their available tools to help companies substitute and the European Textile and Apparel Association (EURATEX) presents their activities to replace harmful chemicals.

Presentations and recording

ECHA webinar: How are substances screened and shortlisted? – presentations and recording available
14 February 2017

The webinar explains the screening process, its timelines, and criteria for short listing. It also explains how registrants can influence the manual screening process by updating their dossiers and how they can obtain more information on common screening. The webinar also gives advice on how registrants should react to the informative letters sent by ECHA to all registrants of shortlisted substances.

Presentations and recording


Calls for information

There are no new consultations this week. Have a look at the 17 currently open consultations on our home page.

All open consultations

 

 

 

 

2017-02-22
Location: Finland
Description:

Compliance checking substances

ECHA has updated the list of substances that might be chosen for compliance checks. There are 60 new substances. Registrants of these substances are strongly advised to update their registration dossiers including the chemical safety report and tonnage band by 28 April 2017. By updating your dossier, you are making sure that ECHA checks the most up-to-date information.

ECHA has published this list since January 2015. This gives registrants the chance to update their dossiers before the compliance check starts. However, the list is indicative and non-exhaustive: ECHA can check the compliance of any dossier at any time and without prior notice.

Substances potentially subject to compliance checks | Compliance checks

ECHA

February Newsletter online

This year’s first issue of the ECHA Newsletter explains what is being done to make sure that registrations are up to the expected standard and tells how the QSAR Toolbox and read-across can help you prepare your registration. You can also read about how companies produce safer textiles and how the construction sector in Sweden makes buildings safer. Our guest columnist also gives you expert advice on data-sharing.

The Newsletter is also always available in PDF format on our Newsletter web page.

ECHA Newsletter | PDF version

REACH

REACH-IT integrated support - translations available

To support companies registering chemicals, REACH-IT now includes integrated support material in 23 EU languages. You can change the language by going to the General settings and clicking on the user icon at the top of the screen.

The Discover REACH-IT short guide helps to introduce companies to REACH-IT and is also available in 23 languages.

Discover REACH-IT | Need further help?

Authorisations granted for various uses of four substances

The European Commission has granted authorisations to eight companies for a total of 10 uses of four substances. The review periods expire on the dates given in brackets:

  • trichloroethylene (EC 201-167-4) - Grupa Azoty S.A. (21 April 2028); Chimcomplex S.A. Borzesti (21 February 2019); Richard Geiss GmbH (two uses until 21 April 2028); Spolana a.s. (21 April 2020);
  • sodium chromate (EC No 231-889-5) - Dometic GmbH/Dometic Hűtőgépgyártó és Kereskedelmi Zrt. (one use until 31 December 2019 and one use until 21 September 2029);
  • sodium dichromate (EC 234-190-3) - Boliden Mineral AB (21 September 2024);
  • chromium trioxide (EC 215-607-8) - Grohe AG (one use until 21 September 2029 and one use until 21 September 2027).

Summary of the decisions of the European Commission

Corrigendum to news item on enhanced completeness check

A corrigendum to the news item ‘Enhanced completeness check delivers its first results’ has been published on our website. The corrigendum clarifies why 5 % of checked dossiers were rejected. We appologise for any confusion this may have caused.

News item

CLP

New intention to harmonise classification and labelling

A new intention to harmonise the classification and labelling has been received for the following substance:

  • n-hexane (EC 203-777-6, CAS 110-54-3).

Submitted proposal | Submitted intentions

Board of Appeal

Announcement of a new appeal

The Board of Appeal has published an announcement of a new appeal. Case A-014-2016 concerns a data sharing dispute under the Biocidal Products Regulation (BPR).

Announcements


Downstream users

Feedback on the interactive guide on safety data sheets and exposure scenarios

Thanks to those who provided feedback. We have now updated the English version of the guide. Versions in other languages will be made available in March 2017.

Interactive guide


Guidance

Addition to a Biocides Guidance document published

The Biocides Guidance Volume III Human Health (Part B) has now been further developed to incorporate Part C on evaluation. Minor editorial corrections have also been made. The new document will be renamed Volume III Human Health, Assessment and Evaluation (Parts B+C).

Guidance on biocides legislation


Events

Need training on Chesar?
6-7 April 2017, Helsinki

We are offering a two-day training session on Chesar on 6-7 April 2017. You need to register. If the demand is high, we may organise a follow up session. Complete this survey by 20 March 2017, so that we can analyse your training needs.

Participation is free of charge, but participants have to cover their own travel and accommodation costs.

Programme | Survey

Seminar on Applying for Authorisation to use an SVHC
18 April 13:30 to 19 April 13:00 Helsinki time (EET, GMT +2)

This seminar focuses on improving future applicants’ knowledge of the REACH authorisation application procedure and will advise how to prepare an application. It will also look at the opinion-making process in RAC and SEAC, how the European Commission makes its decisions and getting practical advice and feedback from previous applicants.

It is free of charge and open to companies planning to apply for authorisation.

Registration

Single Market Forum 2016-2017 – REACH 2018 and beyond
27-28 April 2017, Sofia, Bulgaria

The conference is organised by the European Commission and aims to draw the attention of companies, and especially SMEs, to the obligations they have under REACH. It will also help them to prepare for the upcoming 2018 registration deadline. Participants will be able to book a one-to-one session with an expert on REACH to get tailor-made advice.

Participation is free of charge.

Event information and registration


Calls for information

Public consultation on harmonised classification and labelling

ECHA is looking for comments on the harmonised classification and labelling proposals for:

  • 2-methylimidazole (EC 211-765-7; CAS 693-98-1). The substance is used mainly as an intermediate for the manufacture of other chemicals like pharmaceuticals, agrochemicals, dyes and pigments, and as a catalyst in polymer production. It has no existing harmonised classification and labelling in Annex VI to CLP. We invite you to provide comments on the reproductive toxicity hazard class.
  • octamethylcyclotetrasiloxane; [D4] (EC 209-136-7; CAS 556-67-2). The substance is used in diverse applications including uses at industrial sites. It has an existing harmonised classification and labelling in Annex VI to CLP as Repr. 2 and Aquatic Chronic 4. We invite you to provide comments on environmental hazard classes.
  • MCPA-thioethyl (ISO); S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate (EC 246-831-4; CAS 25319-90-8). The substance is a plant protection product used as a herbicide and plant growth regulator. It has no existing harmonised classification and labelling in Annex VI to CLP. We invite you to provide comments on all hazard classes (physical, human health and environment hazard classes), except respiratory sensitisation and hazardous to the ozone layer.

The deadline for comments is 7 April 2017, 23:59 Helsinki time (EET).

Give comments

Have a look at the 19 currently open consultations on our home page.

All open consultations

 

2017-02-21
Location: Europe
Description:

Brussels Update: EU Regulatory Developments and their Impact on the Global Industry

by Rania Georgoutsakou, director, Public Policy, SEMI Europe

A number of EU regulations will be amended or enter into force in 2017, and each of these can potentially impact how SEMI members do business in Europe.

Here’s a checklist of what to prepare for:

  • PFOA restricted in the EU – The use of PFOA, its salts and PFOA-related substances will be restricted under EU REACH, impacting primarily material and equipment suppliers. The substance is used as process chemistry for some device manufacturing and may also be present in chemical containers, vessels, tubing, gaskets, ductwork, filtration, and coatings in semiconductor manufacturing equipment. The EU restriction is expected to enter into force in Q2 2017 and SEMI has successfully advocated for a five-year derogation for semiconductor manufacturing equipment. Materials suppliers will need to verify that their chemical containers do not contain the restricted substances and semiconductor equipment and component suppliers will need to ensure that the substance is not present in their products at the end of the five-year derogation period. Device manufacturers can continue to use the substance for manufacturing, as lithography and etching processes are excluded from the scope of the proposed restriction.

The EU has also recommended that PFOA is restricted globally under the UN Stockholm Convention. This recommendation is currently under review and SEMI has engaged in the Stockholm Convention decision-making process to secure the exemptions SEMI member companies need.  For more details on this development, please see this recent article in SEMI Global Update.

  • EU RoHS 2 to be amended − The Commission has published a proposal to revise the EU RoHS directive, a move that has been expected for some years and aims to avoid some unintended effects of the legislation. The proposals include language to revise the scope of the law and clarify that ‘newly in scope EEE’ (category 11 – EEE that was not in the scope of RoHS 1) can benefit from secondary market operations and can have access to spare parts, if it was placed on the EU market before the compliance deadline of 22 July 2019. The Commission also proposes setting a nine-year maximum validity period for exemptions applicable to category 11 EEE and deleting the six-month deadline for the Commission to decide on industry requests to renew exemptions.  The Commission’s proposals are currently going through the EU decision-making process and will be reviewed and voted on by the EU law-makers (European Parliament and Council). Semiconductor manufacturing equipment benefits from the ‘large scale’ exclusions and is not subject to EU RoHS requirements (exemptions for large scale stationary industrial tools and large scale fixed installations), and SEMI will be monitoring the process to ensure any revisions to the legal text do not have an adverse impact on SEMI members
  • Applying REACH to very complex products – The “what is an article?” debate will continue in 2017, with the EU expected to finalize its revised guidance on how to apply the EU REACH requirements on ‘substances in articles.’ The revision process was triggered by the September 2015 ruling of the European Court of Justice, that changed the interpretation of the term ‘article’ to mean individual components and objects that are assembled into a larger products, rather than the complex, assembled product itself, and thereby increased the burden on importers and manufacturers of products in the EU.

SEMI is a member of the partners expert group (PEG) set up by the European Chemicals Agency to revise the guidance and has been advocating for a practicable and enforceable solution that acknowledges the realities of very complex products and global supply chains.

SEMI members are collaborating to develop guidance specifically for semiconductor manufacturing equipment, building on the consensus achieved with national authorities and other stakeholders in the expert group. This guidance will help SEMI member companies refine their due diligence processes and communicate with their supply chains in order to comply with the EU REACH requirements on substances in articles. To find out more or to get involved, please contact me (gourania@semi.org).

  • EU Conflict Minerals law to enter into force – EU legislators have reached an agreement on the new EU rules for responsible sourcing of conflict minerals and the legislation should enter into force by the end of 2017 . Under the new EU rules, due diligence in accordance with the OECD guidance will be mandatory for 95 percent of EU importers of tin, tungsten, tantalum and gold and their ores as of January 2021.  Downstream companies are encouraged to undertake due diligence voluntarily, and their level of engagement will be one of the elements reviewed two years after the law is applied with a clear mandate to introduce mandatory requirements for downstream companies if progress is unsatisfactory. Larger downstream companies (above 500 employees) in particular that are subject to the new EU law on ‘non-financial reporting’ and use ‘conflict minerals’ will find new performance indicators encouraging responsible sourcing of conflict minerals included in the compliance guidance to this new law .

    At a time when there is speculation about the future of U.S. requirements on conflict minerals under the Dodd-Frank Act, the EU law may can be reasonably expected to continue to drive for responsible sourcing and reporting of conflict minerals not only from the Great Lakes Region, but from any ‘conflict-affected or high-risk’ area around the world.
  • Ecodesign moving beyond energy-efficiency – EU eco-design rules, that have so far focused primarily on energy savings, will increasingly set out horizontal requirements for resource efficiency and providing information to ease of reuse and recycling, as was clearly stated in the long-awaited 2016-2019 EU Ecodesign Working Plan.

A recent example is the proposed EU eco-design requirements for electronic displays, that will also impact displays integrated into other products: the proposal requires the use of logos to indicate the presence of mercury or cadmium in the electronic display, as well as information on the location of all components containing the above two substances plus indium (the latter is classified as a critical raw material and therefore a substance the EU is keen to recover more of at a product’s end of life).

SEMI is currently or has in the past engaged in advocacy activities on all of the above issues, voicing members’ concerns and needs and trying to shape a positive business environment through regular constructive dialogue with decision-makers and other stakeholders.

SEMI’s advocacy work in Europe is driven by members – we manage a number of communities where members are regularly alerted to latest developments, exchange views with peers on the potential implications for the industry and forge a consensus on how to improve and comply with EU laws. 

For more information and to get involved, please get in touch! Rania Georgoutsakou in SEMI Europe  (gourania@semi.org) or Sanjay Baliga (sbaliga@semi.org) in SEMI headquarters.

Global Update
SEMI
www.semi.org

Application: Environment
REACH - Start year: : 2007
Description:

Registration, Evaluation, Authorisation and Restriction of Chemicals

Notes:

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. 

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

Start Year / Status
Application: Health
REACH - Start year: : 2007
Description:

Registration, Evaluation, Authorisation and Restriction of Chemicals

Notes:

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. 

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

Start Year / Status
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