ECHA- Actualités

ECHA Actualités: Share information about REACH 2018, new infographic available; 53 new substances to be evaluated; New consultations for harmonised classification and labelling; New CLH consultation launched on the pesticide Spirodiclofen; Registry of intentions updated; RMOA of Copper Sulphide; Commission invites comments on restricting 291 substances; New version of Epic available, changes for companies notifying exports of mixtures; Epic tool update; Advice to epic chemicals exporters ; Are you planning to export PIC chemicals in 2016 ? Notify your intentions now; Update to guidance on information requirements and chemical safety assessment; Expert workshop on health impacts of chemicals; Board of Appeal decides in case a-006-2014 on the substance evaluation of Hexyl Salicylate


« Share Information About REACH 2018 – New Infographic Available »-ECHA

« Do you know companies who are dealing with chemicals and might need to register them with ECHA to stay on the market after May 2018 ? Do you know companies who know their obligations but have not yet started the work? Share the information from our REACH 2018 web pages and remind them of their tasks with our new infographic. Remember also that preparing a registration can take anything between six months to three years. So, starting as soon as possible is key to a successful registration. (…) »
Sources :
ECHA Newsletter 28.10.2015 :
REACH 2018 web pages :


« Evaluation- 53 New Substances To Be Evaluated »-ECHA

« ECHA has prepared a proposal to update the Community rolling action plan for 2016-2018. The Member States are planning to evaluate 138 substances, out of which 53 are newly selected. The final plan will be adopted in March 2016.
The draft plan has been prepared in close cooperation with the Member States, taking into account risk-based criteria for the selection of substances. ECHA encourages registrants of the listed substances to start coordinating their actions and to contact the evaluating Member States. (…)«
Sources :

ECHA Newsletter 28.10 :
News alert :
Draft CORAP 2016–2018 :
Draft Corap list :
Updated CORAP :

Classification& Etiquetage Harmonisés Consultations publiques

« New Consultations For Harmonised Classification And Labelling »-ECHA

« ECHA has launched public consultations on the harmonised classification and labelling (CLH) proposals for isobutyl methacrylate (EC 202-613-0, CAS 97-86-9) and 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone (EC 404-360-3, CAS 119313-12-1). Isobutyl methacrylate is currently classified in Annex VI of the CLP Regulation. Its most common use is as a monomer for polymerisation or intermediate in synthesis of other chemicals. We invite you to provide comments on the hazard classes eye irritation, skin sensitisation and aquatic acute toxicity.
2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone also has a harmonised classification. It is used as a photosensitive agent in printing inks, pigmented coatings and photopolymers for imaging applications. We invite you to provide comments on reproductive toxicity. Submit comments by 11 December 2015. (…)»
Sources :
ECHA Newsletter 28.10 :
Current CLH consultations :

“New CLH Consultation Launched On The Pesticide Spirodiclofen”-ECHA

“ECHA has launched a public consultation on the harmonised classification and labelling (CLH) proposal for spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate (CAS 148477-71-8). Spirodiclofen has no harmonised classification in Annex VI of the CLP Regulation. It is an active substance used as an insecticide and acaricide. We invite you to provide comments on the following hazard classes: All physical hazards; All health hazards except respiratory sensitisation; All environmental hazards except hazardous for the ozone layer. Submit comments by 4 December 2015. (…)”
Newsletter ECHA 21.10.2015:
Current CLH consultations :
CLH consultation spirodiclofen :

Classification& Etiquetage Harmonisés- Registre d’intentions

« Registry Of Intentions Updated « -ECHA

« Two dossiers for harmonised classification and labelling were submitted by Germany: L-(+)-lactic acid; (2S)-2-hydroxypropanoic acid (EC 201-196-2, CAS 79-33-4) and pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one (CAS 123312-89-0).
The United Kingdom submitted a dossier for thifensulfuron-methyl (ISO); methyl 3-(4-methoxy-6-methyl- 1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate (CAS 79277-27-3). (…)»
Sources :
ECHA Newsletter 28.10 :
Submitted CLH consultations:

“Registry Of Intentions Updated”-ECHA

Eight new CLH intentions have been added to the Registry of Intentions:

empenthrin (ISO) (CAS 918500-11-5)
dibutylbis(pentane-2,4-dionato-O,O’)tin (EC 245-152-0; CAS 22673-19-4)
theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione (EC 200-385-7; CAS 58-55-9)
ethylene oxide; oxirane (EC 200-849-9; CAS 75-21-8)
thiabendazole (ISO) (EC 205-725-8; CAS 148-79-8)
imidacloprid (ISO) (EC 428-040-8; CAS 138261-41-3)
p-mentha-1,3-diene; alpha-terpinene; 1-isopropyl-4-methylcyclohexa-1,3-diene (EC 202-795-1; CAS 99-86-5)
p-cymene; 1-isopropyl-4-methylbenzene (EC 202-796-7; CAS 99-87-6).

Two CLH dossiers were submitted by Germany:

dodecyl methacrylate (EC 205-570-6; CAS 142-90-5)
and tris(2-ethylhexyl) 4,4′,4 »-(1,3,5-triazine-2,4,6-triyltriimino)tribenzoate (EC 402-070-1; CAS 88122-99-0) (…) ».

Newsletter ECHA 21.10.2015:
Current CLH intentions :
Registry of Intentions :
Submitted CLH proposals :

Substances extrêmement préoccupantes

“RMOA Of Copper Sulphide”-ECHA

“A risk management option assessment (RMOA) of copper sulphide has concluded that no action is needed on it at this time. Copper sulphide was selected for assessment because REACH registration data said that, as used in the EU, it could contain an impurity with SVH properties. It therefore potentially fulfilled Article 57 criteria where the concentration limit of the impurity exceeded the generic concentration limit relevant for classification as a CMR category 1A/1B.  Also, the substance is registered for uses within the scope of authorisation. These include in:• processing aids;• lubricants, greases and release products; and • the production of brakepads.
However, a subsequent update of the registration data showed that copper sulphide, as used in the EU, does not contain the impurity that caused it to be selected. It will, though, be re-screened at a later date to consider new information.(…)”
Sources :
Newsletter ECHA 21.10.2015:
RMOA copper sulphide:

« Commission Invites Comments On Restricting 291 Substances »-ECHA

« The European Commission has launched a public consultation on its proposal to restrict 291 substances that are carcinogenic, mutagenic or toxic to reproduction (CMR). The aim is to target hazardous substances in textile articles and clothing for consumers. The Commission seeks views on whether its plan is proportional and enforceable, on potential socio-economic impacts and on the likelihood of the identified CMR substances being present in consumer textile articles. The list of CMR substances (individual substances or groups) covered by this possible restriction would be added as a specific appendix to Annex XVII to REACH and could be regularly updated. Please submit your comments at the latest on 22 January 2016. (…)»
Sources :
ECHA Newsletter 28.10 :
Public consultationCMR :

Export- Import de Produits chimiques dangereux

“New Version of EPIC Available – Changes For Companies Notifying Exports Of Mixtures”-ECHA

“An update of the IT tool used for submitting export and import notifications under the Prior Informed Consent (PIC) Regulation has now been published. It includes a change for companies notifying mixtures which contain a substance included in an Annex I group entry. (…)”
Sources :
Newsletter ECHA 21.10.2015:
ePIC support page :

“EPIC Tool Update”-ECHA

“Echa has updated the IT tool, used for submitting export and import notifications under the prior informed consent (Pic) Regulation.The new version includes a change for companies notifying mixtures containing a substance included in an Annex I group entry. Companies must now give a Cas or EC number for the actual substance used in the mixture, instead of just referring to the generic group entry.
The agency says this will help to:

• clearly identify the substance already in the notification (and not only in the safety data sheet);
• ensure faster decision making for the importing country; and
• simplify Article 10 reporting for companies as ePIC will automatically prefill the substance information.(…)”

Newsletter ECHA 21.10.2015:
EPic tool update :

“Advice To Epic Chemicals Exporters”-ECHA

“The agency is advising all exporters of ePic chemicals in 2016 to notify their intentions now. It has issued specific reminders to supply up-to-date information on importers, and that the IT tool ePic requires Cas/EC number of actual substance used in any mixture or article. The ePic IT user manual or Echa’s helpdesk are recommended for additional guidance. (…)”
Sources :
Newsletter ECHA 21.10.2015:
Advice to ePic chemical exporters:

“Are You Planning To Export PIC Chemicals In 2016? Notify Your Intentions Now”-ECHA

“To allow national EU authorities and ECHA enough time to process the notifications, and the importing countries time to respond, we recommend that you submit your export notifications for 2016 at your earliest convenience. When preparing your notification, we ask you to provide more detailed information about the importer. For example, up-to-date contact details with a full street address will help the authorities in the receiving country to process your notification faster.
Remember also that the new version of the IT tool ePIC requires those submitting notifications for mixtures/articles with group entries, to specify the CAS/EC number of the actual substance used in the mixture/article. If you have any doubts, have a look at the updated ePIC IT user manual or contact ECHA through our Helpdesk.(…)”
Export notifications :
ePIC user manual :
News item :
Newsletter ECHA 21.10.2015:
ECHA Helpdesk :

Guide ECHA

« Update to Guidance on Information Requirements and Chemical Safety Assessment (version 3.0) »-ECHA

« The agency is consulting on amendments to Chapter R.7b: Endpoint specific guidance (version 3.0), concerning the sediment compartment. Echa has published a corrigendum to Chapter R.7a of its Guidance on Information Requirements and Chemical Safety Assessment (IR&CSA). The agency says the Partner Expert Group (PEG) discussed and agreed additional text for a bullet point on respiratory sensitisation. It was to be added to avoid the possibility of misinterpretation or misunderstanding. However, it was accidentally omitted in drafting. (…)”
Newsletter ECHA 21.10.2015:
Corrigendum IR&CSA guidance :
REACH guidance consultation :


« Expert Workshop On Health Impacts Of Chemicals »- ECHA

« The agency is to host an expert workshop in Helsinki on 11-12 January 2016 on the valuation of health impacts of chemicals. Participation is by invitation only and aims to facilitate exchange of ideas between researchers in North America and the EU. To be presented and discussed are state-of-the-art studies that elicit willingness-to-pay values for health endpoints, associated with hazardous chemicals.(…) »
Event details chemical health impacts workshop :


« Board Of Appeal Decides In Case A-006-2014 On The Substance Evaluation Of Hexyl Salicylate »-ECHA

« In case A-006-2014, the appellant contested ECHA’s decision requesting an in vitro dermal absorption study, a 28-day repeated dose toxicity study and information on worker and consumer exposure, following the substance evaluation of hexyl salicylate. The Board of Appeal decision examines the scope of the substance evaluation process and the conditions that need to be met in order for the Agency to justify a request for further information. The Board of Appeal dismissed the appeal on the grounds that ECHA had not exceeded the scope of its powers in requesting exposure information from individual registrants and in requesting information on an endpoint that was not the reason for the inclusion of the substance in the community rolling action plan. The Board of Appeal also found that the request for a 28-day repeated dose toxicity study was proportionate as the test is necessary to clarify a potential risk to human health and the environment. (…) »
Sources :
ECHA Newsletter 28.10 :
Board of Appeal decisions :

Pertubateurs Endocriniens- Actualités

Pertubateurs Endocriniens- Actualités : Synthèse INSERM, les Perturbateurs endocriniens; European Commission’s 2016 work plan missed opportunity on Endocrine Disrupting Chemicals


« Dossier- Les Perturbateurs Endocriniens »- Inserm

« Dossier réalisé en collaboration avec Robert Barouki (unité 1124 Inserm/Université Paris Descartes, Toxicologie, pharmacologie et signalisation cellulaire, Paris)
Les perturbateurs endocriniens regroupent une vaste famille de composés capables d’interagir avec le système hormonal, et notamment avec notre métabolisme ou nos fonctions reproductrices. Leur étude représente un enjeu majeur pour la recherche, le corps médical et les pouvoirs publics car les sources d’exposition sont nombreuses et difficiles à maîtriser, tandis que les conséquences biologiques de ces expositions sont encore mal appréhendées et complexes à étudier.
Dossier réactualisé et complet abordant les thèmes : le système hormonal sous le feu des perturbateurs endocriniens ; Air, eau, aliments… : les sources d’exposition multiples; La recherche face à de nouveaux paradigmes;actualités, communiqués de presse, expertises collective de l’Inserm, autres sources et vidéos (…) »
Source :

Commission Européenne

« European Commission’s 2016 Work Plan ‘Missed Opportunity’ on EDCs »- Chemical Watch

« The European Commission says it will conclude its preparatory work on the dangers of endocrine disruptors and “follow up on it” in its 2016 work plan, released this week. In January, the Commission said that a legislative proposal on endocrine disrupting chemicals (EDCs) criteria would be issued, after an impact assessment is concluded « in 2016 ». This assessment started last year, following publication of the EDC roadmap. A public consultation organised to feed into this ended in mid-January . (…) »
Sources :
Commission Work Programme 2016 :

Biocides- Actualités

Biocides Articles: Registry for biocidal products (R4BP3) updated; Contact your National helpdesk to check if your product falls under biocides legislation; Board of appeal dismisses Biocides data-sharing case

“Registry For Biocidal Products (R4BP 3) Updated”- ECHA

“A new version of R4BP (3.4) introduces the possibility to exchange XML files under “Ad-hoc communication”. The update also includes minor bug fixes and improvements in usability.(…)”
Newsletter ECHA 21.10.2015:
R4BP 3 support page :

« Contact Your National Helpdesk To Check If Your Product Falls Under Biocides Legislation »-ECHA

« The European Commission and Member States have repealed the Manual of Decisions concerning the old Biocidal Products Directive. Companies who, on the basis of the manual, considered their product to be excluded from the scope of the biocides legislation can contact their national helpdesk to check whether the status has changed. If the product could now fall under the new Biocidal Products Regulation, companies can submit a declaration of interest to notify to ECHA until 3 October 2016. (…)»
Sources :
ECHA Newsletter 28.10 :
News item :

« Board Of Appeal Dismisses Biocides Data-Sharing Case »- Chemical Watch

« Echa’s Board of Appeal (BoA) has dismissed an appeal against Echa’s decision to grant a company inclusion on the biocidal product Regulation’s (BPR) Article 95 list of approved substance suppliers, without access to a vertebrate study. (…) »
Source :
BoA decisions :

« Microbilles Plastiques dans Les Produits Cosmétiques : Sur La Voie De L’interdiction En Europe »- Cosmed

« Les microbilles plastiques synthétiques, sont de minuscules morceaux de polyéthylène mesurant 5 mm ou moins. Les études scientifiques ont montré que ces microbilles plastiques synthétiques ne se désagrègent pas et s’accumulent dans les cours d’eau. Elles sont jugées nocives pour les poissons et autres organismes aquatiques.
microbilles 2Trois états aux États-Unis, ainsi que le Canada, ont déjà décidé de réduire l’usage des microbilles de plastique. Les Pays-Bas, l’Autriche, le Luxembourg, la Belgique et la Suède ont appelé à une interdiction progressive. (…) »

Lire la suite…

Source :
« Newsletter Cosmed n°40 – La lettre d’information»

Enquête Cosmed sur les Conservateurs en Cosmétique

« Au fil des réévaluations réglementaires, la liste des conservateurs autorisés en cosmétique s’est progressivement réduite.


Sur une soixantaine de conservateurs autorisés dans l’annexe 3, seuls une vingtaine sont réellement utilisés par l’industrie pour des raisons de conservation, de formulation, de solubilité, mais aussi des attentes du consommateur.

Or, réduire davantage cette liste développerait les risques de résistance aux antimicrobiens liés à l’exposition des populations à seulement quelques conservateurs.
Les discussions actuelles autour du PHMB illustrent cette problématique. (…). Afin de défendre l’utilisation du PHMB à une concentration inférieure à 0.3 %, Cosmed souhaite alerter la C.E. sur l’impact économique de cette décision sur les entreprises. Pour chiffrer ces données, Cosmed mènera dans les prochains jours une enquête auprès de ces adhérents. (…)»

Lire la Suite …

Source :
« Newsletter Cosmed n°40 – La lettre d’information»

SCCS Standing Committee on Cosmetic Products-22.10.2015

Presentation: Draft Agenda and Committee Meeting Measures

Draft Agenda (22.10.2015)

1.Adoption of the agenda

2.Adoption of the minutes of the Standing Committee on Cosmetic Products of 26.06.15

3.Measures for vote

Draft Regulations on : trimethylbenzoyl diphenylphosphine oxide (TPO), Quaternium-15, diethylene glycol monoethyl ether (DEGEE); potassium hydroxide (KOH), authorization of Zinc Oxide (nano) and Carbon Black (nano)

4.Issues for discussion
Nanomaterials : Draft regulation on the authorization of Titanium Dioxide (nano) – update, Catalogue of nanomaterials
CMR substances : Draft Regulations on formaldehyde, on PHMB; 2-Chloroacetamide – update
Other substances
Draft Regulations on : HWP and peanut oil , Methylisothiazolinone – update; Ethyl lauroyl arginate HCl – update; restriction of Zinc Oxide as a colorant – update

5.State of play RAPEX

 Committee Meeting Measures

->The European Commission’s Standing Committee on Cosmetics Products has voted to approve the use of zinc oxide as a UV filter.

According to the Committee, the compound is considered safe to use both in its nano- and non-nano form, and also suitable as an alternative to some UV filters suspected of being endocrine disruptors.

The committee also voted to approve:

* KOH for use in cosmetic products that remove or soften calluses. The use of KOH is already allowed in other types of cosmetic products, including cuticle removers and ph regulators;

* TPO as an ingredient in nail modelling products, for professional use. Classified as CMR, it was considered safe for use in such products by the SCCS. The substance is considered to be allergenic, and, therefore, permitted only for use by professionals.

*In addition, the meeting voted to officially remove Quaternium-15 from the list of authorised preservatives under the cosmetics Regulation. The compound is due to be classified as a CMR and is already banned in cosmetic products.

* The Committee decided on concentration limits for use of DEGEE, in line with an assessment by the SCCS.

Sources :
Agenda :
Draft implementing measures :

Associated Documents:
*D041827/01 (Draft implementing measure/act)
Commission Regulation (EU) amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
*D041818/01 (Draft implementing measure/act)
Commission Regulation (EU) amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
*D041688/01 (Draft implementing measure/act)
Commission Regulation (EU) amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
*D041567/01 (Draft implementing measure/act)
Commission Regulation (EU) amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

Minutes- SCCS 11th Plenary Meeting

Minutes of the 11th SCCS Plenary (Meeting date: 29.09.2015)

1.Minutes of the previous meeting 25 march 2015
Minutes adopted on 24/07/2015 through written procedure and published on the website.

2.Information from chair/members/commission

• Four SCCS Opinions have been sent for publication: Aluminium, Beta-Arbutin, PHMB and TiO2 (nano).
• ECHA received the comments and attachment from SCCS during the public consultation on 2-methylisothiazol-3(2H)-one (MIT) and these have been included in the Response to Comments (RCOM) document which will be provided to the dossier submitter and RAC for their responses.
• DG GROW informed about a workshop planned on cosmetic product preservation, (21 October, Brussels) and invited few members from SCCS to participate together with the Secretariat.

3.New Requests/Mandates
Mandates adopted; rapporteurs appointed for TiO2 (nano) in spray products –submission II

4.Draft Opinions On

SYNBIO 3RD OPINION: preliminary opinion published for public consultation between 15 July and 16 September. The public consultation finished on 16 September. 61 comments were received from 12 different organisations – NGOs/universities/public institutions. Secretariat prepared a table of comments and sent them to the Chair and the Rapporteur. Commission informed about a workshop to be held in Luxembourg on 10 December and invited a member of SCCS to participate – one of the Vice Chairs is planning to participate.

*Cosmetic Ingredients

UV filter S86 Phenylene Bis Diphenyltriazine was adopted by written process on 13/07/2015 and published.
The SCCS considers Phenylene bis-diphenyltriazine, S86, not safe for use as a UV-filter in sunscreen products in a concentration up to 10.0 % taking into account the scientific data provided. SCCS cannot exclude that Phenylene bis-diphenyltriazine may have a genotoxic potential.
The tests conducted on eye irritation and skin sensitisation are considered inconclusive. The phototoxicity potential can as yet not be excluded. This Opinion does not apply to inhalation exposure of Phenylene bis-diphenyltriazine since no adequate information on chronic or sub-chronic toxicity after inhalation was provided. The SCCS noted that due to the poor biodegradation potential and the very high octanol-water partition coefficient, long-term effects or bioaccumulation of Phenylene bis-diphenyltriazine, S86, in the environment cannot be excluded. The use of Phenylene bis-diphenyltriazine as an ingredient in sunscreen products might lead to environmental exposure.

*Hair Dyes/Fragrances

BMHCA, fragrance 2-(4-tert butylbenzyI)propionaIdehyde adopted by written process on 12/08/2015 and published.
SCCS is of the opinion that BMHCA is not safe for use as fragrance ingredient in cosmetic leave-on and rinse-off type products, neither at concentration limits according to the ones set up by IFRA in 2013 (MoS = 3.6) nor at concentration limits as set up by IFRA in the revised proposal that has been submitted in 2015 belatedly (MoS = 53). In addition, no firm conclusion could be drawn on mutagenicity. BMHCA poses a risk of inducing skin sensitisation in humans.

*Nanomaterial in cosmetic ingredients

Hydroxyapatite: the draft opinion discussed and is planned to be adopted in October by written procedure in order to respect the legal deadline.
Silica (nano): a revised version of the opinion been adopted following comments received. be published on the website


9th revision of the Notes of Guidance: document discussed, finalised and adopted. be published after editing process.

5.Comments On Opinions Adopted

*Cosmetic Ingredients

The SCCS answers to comments received adopted and be sent out.

*Hair Dyes

Addendum to the scientific Opinion on the safety of oxidative hair dye substances and hydrogen peroxide in products to colour eyelashes (SCCS/1553/15)
SCCS answers to comments received adopted and be sent out.

*Nano in Cosmetic Ingredients

Opinion on Silica (nano) (SCCS/1545/15)
SCCS answers to comments received adopted and be sent out.

6.Any Other Business

*Next working group meetings :

WG on cosmetic ingredients and hair dyes : 28-29.10, 2-3.12.2015:
WG on methodology : 03-04.11.2015
WG on nano in cosmetics : 13.11.2015

*Next plenary meetings :15.12.2015 , 16.03.2016