Embed Size (px)
Citation preview
1 December2014
6
3 Advance notice on substances being looked at for risk management
On ECHA’s website, there’s a new tool thatyou can use to see the substances that arebeing considered for risk management.ECHA Newsletter explores what benefitsit brings.
4 Top tips for the CLP 2015 deadline Do you know what you need to do to comply with the Classification, Labelling and Pack-aging (CLP) Regulation? Are you aware of the impact the CLP deadline on 1 June 2015 has on your company? ECHA Newsletter has gathered some frequently asked ques-tions related to the CLP deadline to help you in your preparations.
10 Using read-across and categories to improve the safety of nanomaterials Read-across and category approaches are used to predict properties of substances for which there is not enough experimen-tal data. This is a pragmatic way to bridge data gaps to characterise the hazards of na-nomaterials. ECHA Newsletter spoke with Dr Wim de Jong and Dr Robert Landsiedel about recent developments in this field.
12 Your feedback improves the Biocides tool The new release of the Biocides tool R4BP 3 was published in early December. It is a major upgrade that comes with many new features making it easier for applicants to submit their biocides applications. Read what you can do with the new features and learn about the new editor for creating summaries of product characteristics.
We're taking your feedback on board
11 DECEMBER 2014annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu
Welcome to the last Newsletter of 2014. Doesn’t time fly! At this time of year, weget an extra special Christmas gift from all of you – your feedback on our Communi-cations products. It is great for us as we see whether our hard work over the previ-ous twelve months has been appreciated. I was delighted to hear that you’re verypleased with the information we provide, but just as delighted to get your tangibleideas for improvement.
I’d like to say a massive thank you to the over 2 300 of you who gave us feedbackon our news products and the nearly 750 who responded to the web user survey.We’re still analysing the web survey results, but you can see in this edition the changes we’re planning to make on our news products. And, if you’d like to see an overview of the survey results, they are on the website.
The feedback this year highlighted things that you want to read more about. Themost popular topics are those related to downstream users, authorisation, re-striction and classification and labelling. You’re also clearly looking for practical examples and best practice that helps you to plan, prepare and fulfil your responsi-bilities. We’re going to include more content to meet that request.
But therein lies a challenge for you. Practical examples and front line best practicecan only come from YOU! So please, don’t be shy – get in touch with us if you have
2
In this issue: 3 Advance notice on substances being looked at for risk management4 Top tips for the CLP 2015 deadline6 Guest column: Jaguar Land Rover8 Does the new Biocides Review Programme Regulation affect you?10 Using read-across and categories to improve the safety of nanomaterials12 Your feedback improves the Biocides tool14 Introducing one of the new CLP pictograms – serious health hazard15 Using REACH to business advantage17 Challenges posed by ECHA's new liaison person in the European Parliament18 Croatia – a fast learning curve19 Cosmetics – to test or not to test?20 Improving ECHA's news products
To subscribe to ECHA news, register at: http://echa.europa.eu/subscribe
Disclaimer: The views presented in the Newsletter do not necessarily represent the official position of the European Chemicals Agency. All the links are up to date at the time of publication.
ISSN: 1831-4953
Editor-in-chief: Lindsay Jackson Editors: Päivi Jokiniemi, Hanna-Kaisa Torkkeli
European Chemicals AgencyAnnankatu 18, P.O. Box 400,FI-00121 Helsinki FinlandTel. +358 9 6861 80Fax +358 9 6861 8210
http://[email protected] @ EU_ECHALike us on Facebook Follow us on LinkedIn
“We will point you to our ECHA-term
database where information is available in 23
languages”
Head of CommunicationsLindsay Jackson
Next issue of the News-letter will be
published in mid-February
a story to tell that others could be interested in. In this edition, we have a guest column from Jaguar Land Rover, and interviews with Gaches Chimie and nanomaterial experts from the National Institute for Public Health and the Environment in the Netherlands and BASF. An interview in a previous edition with a British SME resulted in them being filmed for Euronews, so you can turn your approach to chemical safety into a marketing benefit too.
Most of you are very satisfied or satisfied with the online format, which was launched in December 2012, but many of you wanted to have a pdf version too. That pdf version is actually already there, so we’re going to increase its visibility.
While the weekly e-News remains well appreciated, there are also some areas that you highlighted where we could continue to improve. Nearly half of you said that you were SMEs, and we are trying to make sure that we give you enough useful information without overcomplicating things. We’re going to keep on trying to simplify the language we use, so that those of you reading in a language that is not your own can understand more easily. We’re also going to point you more often to our ECHA-term database where information is available to you in 23 EU languages.
We received a lot of comments about making the chemical identity of a substance more clear. We will make sure that when a chemical name is pub-lished in the e-News, we also publish the relevant CAS or EC numbers where this is possible. This should make it easier for you to know exactly which chemicals are being discussed.
Your feedback on the ongoing consultations section of the e-News has also been noted and we are going to improve that in the future too. When there are new consultations, we will now highlight these in the e-News.
Wishing you all a wonderful Christmas time and a happy and healthy New Year.
© ECHA
3
SVHC RoadmapAdvance notice on substances being looked at for risk management
reach
On ECHA’s website, there’s a new tool that you can use. It is called the Public Activities Coordination Tool (PACT) and it lists the substances that are being considered for risk man-agement. ECHA Newsletter explores what benefits PACT brings.
Member States and ECHA (if requested to by the European Commis-sion) can carry out a Risk Management Option Analysis (RMOA) to decide whether further risk management activities are needed for a substance. The RMOA identifies the most appropriate route to take in order to ad-dress a substance of concern.
WHAT IS AN RMOA?
For the first time, you can see what sub-stances are being analysed for possible fur-ther risk management before they become part of a formal risk management process.
TEXT BY PAUL TROUTH
WHO BENEFITS FROM PACT?
PACT benefits anyone who wants to know when a substance is on an authority’s radar for regulatory risk management. For the first time, you can see what substances are being analysed for possible further risk management before they become part of a formal risk management process, for example, harmonised classification and labelling, identi-fication of substances of very high concern (SVHCs) or restriction.
WHAT USE CAN I MAKE OF THE ADVANCE NOTICE?
The advance notice enables com-panies to consider their business strategy. Early awareness that a substance may be taken down a risk management route could encourage companies to assess how they are using the substance and whether or not it is possible to replace it with a safer alternative.
It also gives everyone much more time to prepare contributions to the public consultations, which are run during the formal risk management processes. Anyone with data on the substance, information on safer alternatives or other material will have more time to make their case. Registrants also have the chance to make sure that their registration data is up to date.
WHAT INFORMATION IS INCLUDED IN PACT?
You can see: 1. The authority that is developing
the Risk Management Option Analysis (RMOA).
2. The particular concerns being looked at (carcinogenic, mutagenic or toxic to reproduction (CMR), sensitiser, endocrine disruptor or persistent, bioaccumulative and toxic (PBT)).
3. Upon completion of the RMOA, the conclusions that are published. This document gives the conclusion on the next risk management steps, if any.
WHAT HAPPENS WHEN A SUBSTANCE HAS BEEN LISTED IN PACT?
There is no deadline for perform-ing an RMOA. It can be initiated by an authority at any point and the time it takes to carry out the RMOA can vary greatly depending on the complexity of the case.
If risk management measures are to be taken after the RMOA, the nor-mal procedure will then be followed. Stakeholders should keep an eye on the registry of intentions, which confirms the type of regulatory action to be initiated under REACH or CLP. It also indicates when the relevant dossier is expected to be submitted, which determines the
timing of the formal public consul-tation.
The PACT is available on ECHA’s website and will be updated at the beginning of every month.
Further information:
Public Activities Coordination Toolhttp://echa.europa.eu/addressing-chemi-cals-of-concern/substances-of-potential-concern/svhc-roadmap-implementation-plan/pact
SVHC Roadmap Implementation Plan – RMOA analysishttp://echa.europa.eu/addressing-chemi-cals-of-concern/substances-of-potential-concern/svhc-roadmap-implementation-plan
Registry of Intentionshttp://echa.europa.eu/addressing-chemi-cals-of-concern/registry-of-intentions
© FOTOLIA
4
clp
Top tips for the CLP 2015 deadlineTEXT BY PÄIVI JOKINIEMI
Do you know what you need to do to comply with the Classifica-tion, Labelling and Packaging (CLP) Regulation? Are you aware of the impact the CLP deadline on 1 June 2015 has on your company? ECHA Newsletter has gathered some frequently asked questions related to the CLP deadline to help you in your preparations.
The CLP Regulation requires haz-ardous chemicals to be classified, labelled and packaged appropri-ately before they are placed on the market. The regulation is based on the United Nations’ Globally Harmonised System (GHS) and replaces in a stepwise manner the previous legislation – the Danger-ous Substances Directive (DSD) and the Dangerous Preparations Directive (DPD). Now is the time to act to make sure that you comply with CLP.
RE-LABEL AND RE-PACKAGE YOUR MIXTURES
All hazardous chemicals must be labelled and packaged to comply with the CLP Regulation by 1 June 2015. However, there is a transi-tional period of two years for those mixtures that have already been classified, labelled and packaged under the DPD, and which are on the market before June next year. Such mixtures will only have to be labelled and packaged in accord-ance with CLP by 1 June 2017.
‘Placed on the market’ is a complex notion. In this particular case, it means that, on 1 June 2015, the mixture is no longer owned by the company that produced it – they have placed it on the market. For example, the mixture may still be
in the formulator’s warehouse, but provided they have a proof of sale dated before 1 June 2015 to prove that they no longer are the owner, then they can benefit from the two year transition. Even if the classifi-cation and labelling are according to the DPD, the product can legally be sold for the coming two years. On the contrary, if the mixture is stored in the distributor’s ware-house, but is still owned by the for-mulator, then it must be re-labelled and re-packaged by 1 June 2015.
UPDATE THE SAFETY DATA SHEET
The 2015 deadline also affects the safety data sheet (SDS) of your mixture. Until the deadline, your SDS must include the classification that follows the DPD. From 1 June 2015, the SDS no longer needs to contain the DPD classification, un-less you still have mixtures already on the market as mentioned earlier. The contents of the SDS must match the information given on the label of your mixture.
You may already have the new classification together with the old DPD classification in your SDS. After the deadline for the CLP clas-sification has passed, you should update your SDS and remove the old classification. You do not need
to remove it straight away, but you can do it when the SDS is due for an update for other reasons. However, if the old classification affects the safe use of the product or its risk management measures, the SDS needs to be updated right away.
CLASSIFYING MIXTURES CONTAINING SUBSTANCES CLAIMED CONFIDENTIAL
Both the CLP and REACH Regula-tions make it possible for a supplier to claim their substance confiden-tial. Under CLP, the supplier of a substance in a mixture can request an alternative chemical name for their substance. Alternative names granted under the DPD can also still be used under CLP. Under REACH, the registrant of a substance can claim the IUPAC name confidential and use the approved public name for the substance instead.
However, when the identity of the ingredient substances is not apparent, it may be difficult for a downstream user to decide on the appropriate classification for the mixture. Consequently, to guaran-tee the safe use of the substance and the subsequent mixture, the supplier must forward all relevant hazard information to the down-stream user – even if the name of the substance has been claimed confidential.
Either the alternative name or public name must be given. If the substance is hazardous, the concentration range and classifica-
5
clp
tion must also be available to the downstream user.
HARMONISED CLASSIFICATION AND LABELLING
Certain hazardous substances are subject to harmonised classifica-tion and labelling to ensure an ad-equate risk management across the European Union. These substances are listed in Annex VI to the CLP Regulation, and are also available in the Classification and Label-ling Inventory. The list is continu-ously updated with new entries and amendments.
Sometimes your supplier may provide you with a classification that covers more hazard classes than the ones foreseen by the rel-evant entry in Annex VI to the CLP Regulation. This can be perfectly correct. Based on the CLP Regula-tion, the harmonised classification and labelling is legally binding and all the included hazard classes need to be applied to your classification. However, the supplier is responsi-ble for evaluating all the relevant hazard classes and, if necessary, for adding a self-classification for any additional relevant hazard classes not covered by a harmo-nised classification and labelling. This means that, when classifying your mixture, you need to apply the full classification that you have re-ceived from your supplier, including both the harmonised classification and the possible self-classification.
DOWNSTREAM USER REPORT MAY BE NEEDED
It is possible that in some cases you disagree with the classification that your supplier has provided. If any of your suppliers provide the same classification as yours, no ac-tion is needed. However, if you have only one supplier or you disagree with all of your suppliers, you need to generate a new classification and submit a downstream user re-port to ECHA. The report is created
in IUCLID 5 format and submitted to ECHA through REACH-IT.
More information about the downstream user report and how to prepare and submit it can be found on ECHA’s website.
Further information:
CLP 2015http://echa.europa.eu/clp-2015
Mixture classificationhttp://echa.europa.eu/support/mixture-classification
Webinar material: Mixture classification and communicating safe use of chemicalshttp://echa.europa.eu/view-article/-/jour-nal_content/title/webinar-on-mixtures-classification-and-communicating-safe-use-of-chemicals
Alternative chemical name in mixtureshttp://echa.europa.eu/alternative-chemi-cal-name-in-mixtures
Downstream user reporthttp://echa.europa.eu/regulations/reach/downstream-users/downstream-user-reports
Submitting a downstream user reporthttp://echa.europa.eu/support/dossier-submission-tools/reach-it/submitting-a-downstream-user-report-classification-differences
CLP pictogramshttp://echa.europa.eu/chemicals-in-our-life/clp-pictograms
All hazardous chemicals must be labelled and packaged to comply with the CLP Regulation by 1 June 2015. However, there is a transitional period of two years for those mixtures that have already been classified, labelled and packaged under the Dangerous Preparations Direc-tive (DPD), and which were on the market before that date.
© FOTOLIA
6
communicating about safety
Guest column | Jonathan Swindell, Matthew Griffin, Rebecca Bree
- Jaguar Land Rover
Compliance through efficient substance trackingAuthorisation is a multi-step process which aims to phase out or substitute substances of very high con-cern (SVHCs). Many downstream users have introduced substance tracking procedures to help them meet the deadlines for substituting SVHCs or for submitting an authorisation application to continue using the sub-stance until a suitable replacement has been found.
As manufacturers of complex and technologically advanced products, we at Jaguar Land Rover rely on thousands of different sub-stances that are used along our multi-tiered supply chain. In addition to our ongoing efforts to reduce the risks associated with the use of chemicals in our products at our own sites, it is important to have systems in place to track the regula-tory status of the substances in components on which we rely. We also need to prepare for the potential impact of a substance being removed from the market.
TRACKING SUBSTANCES
Many of our substance tracking activities are coordi-nated through the REACH Task Force of the European Automobile Manufacturers Association (ACEA, Asso-ciation des Constructeurs Européens d'Automobiles), in which Jaguar Land Rover is an active participant.
Since the automotive supply chains are complex, we have to start our substance tracking as early as possi-ble in the authorisation process. So, shortly after a sub-stance is added to the Registry of Intentions, ACEA’s REACH Task Force carries out a survey of its members to determine how critical the substance is to our con-tinued vehicle production. This depends on how often it is used, initial understandings of the availability of technically equivalent substitutes, and the potential impact of substitution on vehicle type-approval. Where a substance is identified as being of critical importance across the industry, ACEA coordinates the tracking of the substance status, and develops contributions to public consultations on the Annex XV dossier and on draft recommendations to add new substances to the Authorisation List.
When a substance is added to the Candidate List for authorisation, more detailed assessments of the impact on the industry of potential substitutions are done. If a substance is added to the Authorisation List, then we as individual companies have to plan to be prepared for the sunset date (the date after which the substance can no longer be used). We will then speak to our own affected suppliers to gain a more detailed picture of alternatives. We need to find out if they meet our technical requirements as well as what their costs
and delivery capacity are.
SUBSTITUTION
Where suitable direct sub-stitutes are available and can be implemented by the sunset date, we will instruct our suppliers to go ahead with substitution. Where no direct substitutes are currently avail-able, we will work with sup-pliers to develop and validate alternatives.
The REACH Regulation allows for continued use of a substance after the sunset date by having an authorisation. We at Jaguar Land Rover do not apply for authorisation ourselves. As an end-user, we can only apply for authorisation for our own use and our immediate suppliers’ right to supply the substance. This means that if the authorisation is to cover all users in our entire supply chain, we have to rely on companies upstream applying for authorisation and we have very little visibility on how this is progressing. The deci-sion on whether the application is approved or denied is also likely to be made only a few months before, or even after, the sunset date, whereas substituting a substance in an automotive production part will take up to four years from when we have validated a suitable alternative.
In most cases, we cannot rely on getting an authorisa-tion and so we must plan for complete substitution of the substance by the sunset date. We know that in the coming years more substances will become subject to authorisation, and the efficiency and effectiveness of our substance tracking systems will become increas-ingly important in ensuring our continued compliance.
From left: Matthew Griffin, Jonathan Swindell.
© JA
GUAR
LAN
D RO
VER
7
communicating about safety
Jaguar Land Rover is the UK’s largest automotive manufacturing business with an expanding global presence. It employs 30 000 people globally.
http://www.jaguarlandrover.com/gl/en/
TRACKING TOOLS
The automotive industry has collaborated to create and maintain the Global Automotive Declarable Substance List (GADSL), which defines certain substances as 'declarable' or 'prohibited', based on the input of REACH and other global, national or regional regulations.
In Europe, the industry has also been subject to the End of Life Vehicles Directive for more than a decade. In response, automotive manufacturers had already put effective substance tracking tools in place before REACH came into effect and we were there-fore already familiar with legislation that had similar requirements to REACH.
Along with most other major automo-tive manufacturers, Jaguar Land Rover uses the Inter-national Material Data System (IMDS) to collect and review information on materials along the entire supply chain. Together with the Global Automotive Declarable Substance List, this results in a complete library of all substances of interest used in automotive parts.
In addition, we have our own Restricted Substance Management Standard (RSMS) that in some cases sets further restrictions and earlier substitution dates than those identified in GADSL. These standards are refer-enced on all our drawings, requests for quotations and our global purchasing terms and conditions, forming an essential part of our contracts with our suppliers. Ad-ditionally we apply the same standards to our materials review process, which covers non-dimensional materi-
als, for example, paints, adhesives and floor cleaners, both for production and non-production use.
Our in-house database hosts multiple substance lists, including GADSL, RSMS and the REACH Candidate and
Authorisation Lists. This allows us to check against the listed substances when reviewing articles and materials from our suppliers, before their ap-proval. We can also search the data-base by name, hazard classification (e.g. all sensitisers) or REACH status (e.g. all Candidate List substances). To-gether, these integrated systems give us a complete picture of all substances used in our vehicles and at our sites.
Jonathan Swindell, Product Stewardship Manager at Jaguar Land Rover Matthew Griffin, Hazardous Materials Technical Spe-cialist at Jaguar Land Rover
Rebecca Bree, Toxicologist at Jaguar Land Rover
JAGUAR LAND ROVER
Rebecca Bree.
© JA
GUAR
LAN
D RO
VER
December 2014 - February 2015
ECHA Management Board: 16-17 December
Tentative dates
Update to the Candidate List of SVHCs: 17 December
Upcoming
Webinar recordings
Presentations and material from previous webinars are available on ECHA's websitehttp://echa.europa.eu/support/training-material/webinars
Member State Committee: 2-6 February
Biocidal Products Committee: 2-6 February
8
biocides
Does the new Biocides Review Programme Regulation affect you?TEXT BY PÄIVI JOKINIEMI
With the new Biocides regula-tion that entered into force on 30 October 2014, the Biocides review programme was updat-ed. It clarifies, for example, the use of nano forms and explains when a new active substance/product-type combination can be added to the review programme.
The review programme is about the examination of existing biocidal active substances contained in biodidal products.
Active substances that may be re-moved from the review programme
The new regulation lists all the ex-isting active substances that were originally included in the review programme. However, this list is being updated to include only sub-stances for which companies have expressed an interest. You still have time to do this. Therefore, check the list (part two of Annex II) care-fully, because the active substanc-es that are there will be removed from the review programme if no company notifies ECHA of their intention to take them over by 31 October 2015. If you use an active substance included in Annex II, you should check with your supply chain that a notification will be made in time in order for you to be able to continue using it.
Nano forms
If you use a nano form of an active substance it needs to be notified as such in order to be introduced in the review programme and to remain on the market. There are two excep-tions to this rule – notification is not needed for silver absorbed on silicon dioxide, and silicon dioxide, because nano forms of these two substances are already included in the review programme. Check with your supply chain that a notification will be made by 31 October 2015 for the nano form you use. Other-
wise the products will need to be removed from the market.
Can your active substance/ product-type combination be added to the review programme?
In exceptional cases, active sub-stance/product-type combinations can be added to the review pro-gramme. This applies to active sub-stances that were already on the market before 14 May 2000, but that were not previously included in the review programme for one of the following reasons:
• If the European Commission or a competent authority has changed its previous advice that the biocidal product was not in the scope of the BPD or that an active substance for a relevant product-type was already notified;
• the active substance benefitted from a derogation for food and feed under the previous regulation; or
• the biocidal product belongs to a different product-type under the BPR compared to the BPD, and contains an active substance that is included in the review programme under the old product-type but not under the new one.
If your active substance/product-type combination fulfils one of these criteria, make a declaration of interest to notify it on ECHA’s website. If the declaration is made because of a change of official advice, you need to submit it within 12 months of the clarification. If your case falls under the two latter categories, the declaration of inter-est must be made by 31 October 2015.
ECHA will publish the active sub-stance/product-type combinations on its website and invite companies to submit a notification. The noti-fication needs to be made within six months from the publication of
© FOTOLIA
9
biocides
Review programme
The review programme was set up by the European Commission under the Biocidal Products Directive (BPD). It is the work programme for the ex-amination of biocidal active substances. These active substances were on the market on 14 May 2000 in biocidal products (for purposes other than scientific or product and process-orientated research and development).
The original Review Programme Regulation was replaced by Regulation (EU) No 1062/2014 which entered into force on 30 October 2014. Biocidal products containing substances in the review programme are allowed to be on the market without an authorisation (pending approval of the sub-stance), subject to national laws.
the active substance/product-type combination.
Adding, changing or removing participants
You can add a new participant to the review programme or replace an existing participant, if all parties agree, by contacting ECHA. Howev-er, the new participant has to have a right to refer to all the data that the existing participant has referred to or submitted for evaluation. The new participant will then also be added to the Article 95 list of active substances and suppliers.
If you are identified as a participant in the review programme but you no longer use the active substance, you can also withdraw your participa-tion.
New, quicker deadlines
To make sure that all the active substances included in the review programme are assessed by 2024, the new regulation defines legal deadlines for Member States to evaluate them. These deadlines can be found in Annex III of the regulation.
How to notify?
If you want to notify the use of a nano form or an interest in an active substance that is currently without any participant, you need to create a IUCLID dossier and submit it using R4BP 3. There is a fee for the noti-fication, but this will be deducted from the amount you have to pay when you later apply for approval of the active substance/product-type combinations. The application needs to be submitted within two
years after ECHA has confirmed that your notification is compliant.
If you want to include a substance in the review programme, you first need to declare an interest through a webform and later notify by sub-mitting a IUCLID dossier through R4BP 3.
If you want to join, replace or withdraw a participant in the review programme, use one of the dedicat-ed web forms available on ECHA’s website.
Further information:
Biocides Legislationhttp://echa.europa.eu/regulations/biocid-al-products-regulation/legislationReview Programme Regulation (EU) No 1062/2014 under Implementing and delegated acts
Existing active substanceshttp://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance
Declaring interest to notify a substance for inclusion in the review programmehttps://comments.echa.europa.eu/com-ments_cms/BiocidesDoINotifySubstance.aspx
Joining or replacing a participanthttps://comments.echa.europa.eu/com-ments_cms/BiocidesJoiningOrReplacing-Participants.aspx
Withdrawing a participanthttps://comments.echa.europa.eu/com-ments_cms/BiocidesWithdrawal.aspx
Biocides terminology – in 23 languageshttp://echa.cdt.europa.eu/Search-ByQueryEdit.do
10
reach
Using read-across and categories to improve safety of nanomaterialsINTERVIEWS BY TIIU BRÄUTIGAM
Read-across and category ap-proaches are used to predict properties of substances for which there is not enough experimental data. This is a pragmatic way to bridge data gaps to characterise the hazards of nanomaterials. ECHA News-letter spoke with Dr Wim de Jong and Dr Robert Landsiedel about recent developments in this field.
What are the main developments regarding the risk assessment of nanomaterials?
Robert Landsiedel, BASF, Germany: We realised a decade ago that nanotechnology would offer great opportunities for improving our lives, but might also bear risks for human health. Since then, research-ers have been studying the toxic effects and underlying mechanisms of nanomaterials.
We now have a good idea of which nanomaterial applications pose a risk to human health and which ones can be used safely. In fact, with industrial nanomaterials, few adverse systemic effects have been reported. Inhaling dust particles is the main route of exposure. There are no toxic effects that are unique to all nanomaterials. In this sense, the nano-specific health effects anticipated years ago have not been confirmed by research.
So, there is no general nanotoxicol-ogy but different nanomaterials have different toxic effects. These need to be identified to ensure their safe use. Nanomaterials are used in various modifications and compositions. It is not possible to run studies with all the potential modifications. Instead, we need to define various groups of particles, according to their potential to cause adverse effects to humans.
Wim de Jong, National Institute for Public Health and the Environ-ment, the Netherlands: I largely agree with Mr Landsiedel that no nano-specific health effects have been identified in the last years, but we need to learn more about particle toxicology. Up to 10-15 years ago, particle toxicology was mainly inhalation toxicology, so we have a lot of knowledge from this area. Inhalation is also one of the most identified health risks from nanomaterials. Now new products are being developed which contain nanoparticles, for example, sun-screens. Here we see other routes of exposure beyond inhalation. So, we are moving from inhalation toxicology to more general toxicol-ogy and here we see that nanopar-ticles behave differently to soluble chemicals.
Both industry and regulators want to develop grouping approaches. Based on the information provided by industry, regulators look at the characteristics of safe materials and the criteria for safe use of a particle. Knowledge about the migration and persistence of na-nomaterials is also becoming more important and triggers concerns.
How do read-across and category approaches relate to this develop-ment? Why are they important?
Robert Landsiedel: Nanomaterials are typically embedded in a product or used on its surface. To become toxicologically relevant, they need to be dispersed or released from the product.
It is neither possible to test each different nanomaterial exposure for all of its toxicological prop-erties, nor do we have a full un-derstanding of how the material properties of nanomaterials may cause adverse health outcomes. As such, classical QSAR computer modelling approaches are not yet capable of providing a sufficient grouping concept.
We propose to use a multi-per-spective approach: rather than taking ‘the long shot’ from material properties to adverse outcomes, we should also look at the steps in between: the life-cycle of the nanomaterial; the exposure; uptake; distribution; biophysical interac-tions; as well as cellular and organ responses, to understand which nanomaterials could be grouped to-
Dr Robert Landsiedel.Dr Wim de Jong.
© ECHA © BASF
11
reach
gether with regard to their adverse health effects.
Wim de Jong: In view of the ex-pected development of new or modified nanomaterials, there is a need for read-across and grouping. To evaluate nanoparticle UV filters in sunscreens, first steps have been made in grouping and read across. These approaches were used to evaluate the same nanomaterial which was produced by different manufacturers. However, for unknown particles, we still have to apply other methods, such as high throughput screening, which gives more information on nanomaterials in a relatively short time. We can also evaluate modes of action or modes of activity. These are mainly used for prioritising nanomateri-als, to find out the most toxic ones where we need more information.
Eventually, this information can be used for grouping low-toxic potential materials and high-toxic potential ones, where more infor-mation and a more complete risk assessment are needed. However, this is still based on animal testing.
We are not yet there in terms of replacing all animal tests, but there are encouraging developments. For example, there are European projects that use high throughput screening to identify modes of ac-tion for toxicity. Common mecha-nisms of action might be a first step to identify specific groups of nanomaterials.
Which common approaches for read-across and categories of conventional chemicals can be applied to nanomaterials? Where do you see the main challenges?
Robert Landsiedel: We already have a lot of tools at hand for grouping, read-across, waiving and catego-ries. The ECETOC taskforce on nanomaterials recently suggested a framework to pull together differ-ent concepts in a multi-perspective approach. The idea is not to restrict grouping to only one aspect, but to
use and combine all the different tools for grouping that are already available.
While the framework for a multi-perspective grouping is already within reach, a major challenge will be the design of a decision-tree and defining the criteria for it. Some criteria for grouping are obvious to apply, such as bio-kinetics, bio-physical interactions or early bio-logical effects, while others, such as long-term effects, are currently being investigated.
The definition of groups and sub-groups will require reference materials and case studies of nano-material examples. The multi-per-spective grouping offers a flexible decision-making framework, which can be used and further developed at the same time.
Another challenge will be the generation of data to assign nano-materials to groups. A substantial amount of data is already available from the physico-chemical charac-terisation of the materials and from short-term inhalation studies.
Wim de Jong: We know that a nanomaterial behaves differently in terms of reactivity, because it is made specifically to be, for exam-ple, a more efficient catalytic agent or colouring agent. There is a rea-son why the nanomaterial has been produced. Why would you otherwise use a nanomaterial if the bulk mate-rial had the same properties?
There are limits to extrapolation, for example, based on information about the toxicity of the chemical structure. Ultimately, however, you also need nano-specific informa-tion. Characterisation is important to identify the nanomaterial.
However, to make a decision on grouping, a list of characteristics is not enough. You also need practical information on different assays. It is still difficult to come to a grouping which would be based on
physico-chemical parameters on its own.
We see also the use of principal component analysis, where a set of characteristics are combined to come to an integrated picture. These are very complicated analy-ses. Here, some kind of grouping is possible, but it is not yet correlated with toxicity.
There is one specific challenge for the near future. Even if you can group some nanomaterials based on the principle component analysis, you want to know what it means for that particular group. How does that group behave in terms of toxicity or adverse effects?
Have the read-across and category approaches reduced the need for animal testing?
Robert Landsiedel: Yes they have. At BASF, we use categories in the risk assessment of applications of nanomaterials. As a result, we do not subject each nanomaterial in each modification to a fixed list of animal studies. Instead, we perform the studies needed for the risk as-sessment of the nanomaterial in its own application. With this informa-tion, we select those materials with sufficiently low hazard for a given application and applications with adequately low exposure.
Industry and authorities share the same ultimate goal of reducing animal testing, but we are not there yet. Animal data will still be needed on some materials. Eventually, we will be able to predict adverse outcome from material properties. Until then, we can do risk assess-ments and work on grouping based on exposure, uptake, distribution, biophysical interactions as well as cellular and organ responses. Several of these data can already be obtained without animal studies; and hopefully more or all of them in the future.
12
biocides
Wim de Jong: Industry is working on a multitude of nanomaterials now. They need to make a choice about which materials fulfil the information requirements and are safe for the market before the dos-siers come to the regulators. So, in a pre-clinical or pre-marketing situation, there are many modifica-tions possible on nanomaterials. High-throughput screening and read-across can be used on the pre-selection of those materials that industry wants to continue develop-ing. However, for the nanomaterial that is finally selected, regulators will not yet rely on grouping and will still need animal data for the risk assessment.
All governments want to reduce animal testing. Categories and grouping is one of the ways to do it, although we still need more infor-mation before these can be applied for nanomaterials.
Further information:
Nano terminology – in 23 languageshttp://echa.cdt.europa.eu/Search-ByQueryEdit.do
Nanomaterialshttp://echa.europa.eu/regulations/nano-materials
Nanotechnologyhttp://echa.europa.eu/chemicals-in-our-life/hot-scientific-topics/nanotechnology
Scientific Workshop – Regulatory Challenges in Risk Assessment of Nanomaterialshttp://echa.europa.eu/en/view-article/-/journal_content/title/topical-scientific-workshop-regulatory-challenges-in-risk-assessment-of-nanomaterials
Dr de Jong and Dr Landsiedel participated in ECHA’s workshop on nanomaterials in October 2014. The workshop brought together almost 200 experts in the risk as-sessment of nanomaterials. They discussed scientific principles and guidelines for assessing human health and environmental risks of chemical substances in nanoform. The workshop also provided a platform for academia and regula-tors to address how the long term challenges from the regulatory perspective can be reflected in research topics on nanomaterials.
DID YOU KNOW?
The new release of R4BP 3 was published in early December. It is a major upgrade that comes with many new features making it easier for applicants to submit their biocides applications. The improve-ments have been developed based on feedback received from users. Read what you can do with the new features and learn about the new editor to create summaries of product characteristics.
TEXT BY LIVIA BRIESE AND PÄIVI JOKINIEMI
Your feedback improves Biocides tool
R4BP 3 is the single point of entry when working on biocides appli-cations. It allows you to securely interact with authorities and is well-protected data archive. There are 27 additional processes which are defined in the Biocidal Products Regulation (BPR) that have been included in this latest version of R4BP 3. You can now do more with this one single tool.
Presenting and connecting data in R4BP 3 is improved. For example,
links between granted authorisa-tions are visible, clearly improving the overview of your products.
With the new release all national authorisations for biocidal prod-ucts and ongoing applications are now in R4BP 3. From 3 December 2014, only one system has been in place: R4BP 3. This means that applications for national authori-sation of biocidal products which started in R4BP2 will be processed in R4BP 3.
Easier mutual recognition in parallel
If you need an authorisation to use your product in more than one Eu-ropean country, you no longer have to submit multiple applications separately. Once you have applied for your initial product authorisa-tion, you can choose all the coun-tries where you want to apply for mutual recognition in parallel and the application will be submitted automatically to all of your chosen countries.
Nominate, delegate and transfer rights
The new release also allows you to nominate, delegate and transfer rights on your products to another
13
biocides
company. For example, if you want a consultant to take care of some of your applications, you nominate them to this role and define which authorisation they are allowed to work for you. You can also allow an-other company to apply for a ‘same biocidal product’ directly in R4BP 3.2 by giving access to the authori-sation in your portfolio. This is the case if another company wants to bring a product on the market that is identical to yours and it is in a country where you are already sell-ing the product. R4BP 3.2 also now enables you to acquire a product or a product range from a competitor. Once the legal entities have agreed, the transfer of the product owner-ship is initiated by the previous owner.
Reduced fees for SMEs
If your company is a small and medium-sized enterprise (SME), you can benefit from reduced fees under the BPR. To do this, you need to submit evidence of your company size to ECHA. You can now apply for a check of your SME status directly in R4BP 3.2. The tool includes a wiz-ard that tells you which documents you need to submit. The wizard also provides additional material if you need more support.
Know what’s going on with your application
R4BP 3.2 sends you email alerts to help you to keep up-to-date with your application. Anytime there is a change in the status of your appli-cation, the system will send you an email message to inform you. It will also indicate if an action is needed.
When you need a paper version of a decision you have received in R4BP 3 you can download a copy of your application in PDF format and print it. Finally, you can also export lists of data on applications and de-cisions from your R4BP 3 account in Excel format for offline use.
R4BP 3.2 sends you email alerts to help you keep up-to-date with your application.
Prepare your Summary of Product Characteristics with the new editor
The Summary of Product Charac-teristics (SPC) is a requirement for many product-related applica-tions. It is a public document and includes, for example, the product trade name and instructions for its safe use. A new online tool, the SPC editor, helps you to create this document in the new format that is necessary for product authorisa-tions. It can be used for single prod-ucts or for whole product families. Soon, the tool will be available in all EU languages and Norwegian.
To get started with R4BP 3.2, check ECHA’s Biocides Submission Manu-als.
Further information:
R4BP 3 support http://echa.europa.eu/support/dossier-submission-tools/r4bp
Biocides Submission Manualshttp://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submis-sion-manuals
SPC editorhttp://echa.europa.eu/support/dossier-submission-tools/spc-editor
News alert about SPC Editorhttp://echa.europa.eu/view-article/-/journal_content/title/new-summary-prod-uct-characteristic-editor-for-biocides-authorisation
Biocides terminology – in 23 languageshttp://echa.cdt.europa.eu/Search-ByQueryEdit.do
© ECHA
14
clp
Introducing one of the new CLP pictograms – serious health hazard
CLP labels are intended to give an immediate visual reminder of chemical hazards, and to give clear and concise precautionary informa-tion, including both an indication of the hazard and the recommended precautionary action. They attract attention to the degree of hazard associated with the chemicals in the product. The visual reminders aim to reinforce precautionary behaviour and protect human health and the environment.
Both precautionary statements and hazard statements are standard-ised. Hazard statements define the nature and, where appropriate, also the degree of hazard. Precautionary statements describe recommended measures to be taken in the case of exposure, to minimise or prevent adverse effects.
To understand the severity of the damage that the product may cause, the Globally Harmonised System (GHS) prescribes one of two signal words for labels. De-pending on the hazard classification of the substance in question, the signal word is either “danger” or “warning”. Danger is used for more severe hazard categories, while warning denotes a less serious hazard. A number of studies found that the presence of a signal word increased the perceived hazard and that, overall, participants recog-nised danger as the key word.
IN THE LIMELIGHT: THE SERIOUS HEALTH HAZARD
One of the newcomers is the seri-ous health hazard pictogram. This pictogram has several nicknames – some call it a 'radiant man', others a 'crumbling' or 'exploding' man. This pictogram can be found for exam-ple, on turpentine, petrol or lamp oils. Its label includes the relevant hazard statements, one or several precautionary statements and the pictogram itself – a red framed diamond with a dark looming figure against a white background, its heart irradiating or exploding.
The serious health hazard picto-gram reflects serious longer term health hazards such as carcino-genicity and respiratory sensiti-sation. If not used properly, the substance may provoke the damage described on the label.
Consumers purchasing a prod-uct that contains a hazardous chemical may have noticed a new look and feel of the labels since December 2010. The change isn’t just related to the way the labels look – it also in-troduces three new pictograms, new signal words and new statements. The 'radiant man' is one of the new pictograms warning about a serious health hazard.
TEXT BY LIVIA BRIESE
© ECHA
15
people and perspectives
Further information:
CLP pictogramshttp://echa.europa.eu/chemicals-in-our-life/clp-pictograms
CLP terminology – in 23languageshttp://echa.cdt.europa.eu/Search-ByQueryEdit.do
The Globally Harmonised System (GHS) of Classification and Labelling of Chemicals classifies chemicals by types of hazard and proposes harmo-nised hazard communication instruments, including safety data sheets for workers and labels (for both consumers and workers). It aims to make sure that information on physical hazards, human health hazards and the eco-toxicity of chemicals is available, in order to enhance the protection of human health and the environment during the handling, transport, storage and use of chemicals.
Within the European Union, GHS was implemented on 20 January 2009, when the CLP Regulation (EC/1272/2008) came into force. The regulation amends and repeals the Dangerous Substances Directive (67/548/EEC) as well as the Dangerous Preparations Directive (1999/45/EC).
BACKGROUND
Using REACH to business advantageINTERVIEW BY VIRGINIA MERCOURI
Gaches Chimie is a growing chemical distributor. It has taken a strategic approach to REACH. The company provides a service to end users to help them to predict the supply of chemicals critical for their busi-ness, and enable them to review their portfolios on time.
Pierre Gaches, who is the main shareholder and managing director of the family business, explains that information and data generated by REACH is growing fast. “In the past, 1 kg of chemicals was travelling in the supply chain with 10 g of data. Now for 1 kg of chemicals you may need up to 1 kg of data in order to provide the chemical, store it, use it and pass it to the next user in the supply chain”. He is quick to point out that the increase in the 'quan-tity' of information comes mostly from REACH. This is to achieve adequate knowledge of the sub-stances in use and to define how to safely use them in compliance with all the regulations. Different sets of
this information are of relevance to different companies.
Gaches Chimie decided to use its chemical expertise to organise this information for the benefit
of its clients who are end users of chemicals. It is tailored to their individual needs. A team of special-ists check which exposure scenarios in the extended safety data sheets
REACH is there to protect us from the risks of using chemicals and to allow industries to grow. There are many ways for companies to turn challenges into business opportunities.
© FOTOLIA
16
people and perspectives
are relevant to the specific uses of their clients. If there are gaps, they explain how to fill them and offer solutions. The service evolves with the needs of the customers and takes into consideration any changes in the regulations. Gaches Chimie continually improves the information they offer and the way that it is offered.
INFORMATION ON CHEMICALS AS A BUSINESS TOOL
When a potential substance of very high concern (SVHC) is identified under REACH, Gaches Chimie pass-es immediately the information to its clients. It then follows the sub-stance from the early stages of the regulatory process. The company also engages in additional research to evaluate what is the likelihood that chemicals that are critical for their clients may disappear from the market in the coming years.
“Our customers expect added value from us and one of the ways to do this is to evaluate the risk of substances becoming obsolete,” says Pierre Gaches. He continues to say that this could be not only because of REACH, but for many other reasons, such as strategic, economic, geographical or geopo-litical reasons or changes in produc-tion. The company also contacts the manufacturers and asks for their intentions to continue supplying the substance or mixtures. “We provide this forecast as early as possible to our customers. In order to help them to manage better any busi-ness risks, we also give them some orientation on possible replace-ment. We explain to them if and when we can provide a replacement and we are clear if we are not able to do it,” says Mr Gaches.
HELPING CLIENTS FOR REACH
According to Mr Gaches it could be easier and cheaper for companies to come together in this way with suppliers or distributors rather
than doing all the analysis on their own. The clients to whom it is most useful are end users of chemicals with large portfolios. The wider the range of substances they use, the more relevant it is for them.
Mr Gaches believes that this approach will become more and more useful to small companies, because of the dynamic nature of REACH and the growing number of substances that are added to the Candidate and Authorisation Lists. Smaller companies and especially those that are end users of chemi-cals are in bigger need to organise this information in order to man-age the REACH requirements and prevent possible negative conse-quences for their business.
There are other ways in which a chemical distributor can help his cli-ents, especially smaller companies, to manage REACH. If the safety data sheets of imported substanc-es are not compliant with REACH, the distributor can step in and help.
Mr Gaches is also optimistic that non-EU companies are becoming more and more convinced of the need to provide information on sub-stances of very high concern in their products which is required by their EU partners to comply with REACH.
He is concerned, however, that some companies still see REACH as a constraint and a cost. He confronts this by explaining that REACH is there to protect us from the risks of using chemicals and to allow industries to grow. He says that there are many ways for companies to turn challenges into business opportunities. The chemi-cal information service developed by his company is one example. It has already helped to improve the reputation of Gaches Chimie and brought it new clients. “We want to reduce this feeling of cost and constraint. That is at the core of our service of early warning for our customers. We want to turn REACH into a business advantage by helping them to find sustainable solutions for the future,” concludes Mr Gaches.
Gaches Chimie is based in Toulouse, France. It is present also in Morocco, Spain and Tunisia. The company is involved in the aeronautic industry, composite materials, water treatment, coating paints and the food industry.
Under REACH, Gaches Chimie has the role of a distributor, importer and downstream user. It employs nearly 280 people.
http://www.gaches.com/
GACHES CHIMIE
17
news from echa
Challenges posed by ECHA's new liaison person in the European ParliamentMrs Julie Girling, from the European Conservatives and Reformists (ECR) Group, has been appointed as ECHA’s new liaison person with the En-vironment Committee of the European Parliament. ECHA Newsletter asked her about her expectations for the com-ing years and how ECHA can continue to improve.
INTERVIEW BY PÄIVI JOKINIEMI
Promoting growth for small and me-dium sized enterprises is something that Mrs Girling sees as important in today’s economic climate. This is also closely connected to ECHA’s work. “ECHA could help SMEs more to cooperate both nationally and internationally, by making it easier for them to share information and save costs. It is important for SMEs to know that they have not been left on their own and there is support available when they need it,” Mrs Girling says. She reminds that one way of doing this is by looking into the processes and seeing where they can be further simplified.
IMPORTANT TO SECURE THE BUGDET
In her opinion, one of ECHA’s priori-ties in the coming years should be to ensure the sound financial basis for its work, particularly by devel-oping a policy around generation and collection of fees. Due to con-tinuing budget cuts this will be in-creasingly important. “I support the need to defend ECHA’s budget for adequate staffing but I believe the overall budget cannot be increased,” Mrs Girling points out.
INCREASING PUBLIC AWARENESS ON ECHA'S WORK
The cornerstone of ECHA’s work is to protect human health and the
environment. Mrs Girling suggests that ECHA should do more to make EU citizens aware of this. “ECHA should become closer to EU citizens and explain to them how their work helps, for example in protecting the environment. The work that ECHA does should reassure them about
Mrs Julie Girling is ECHA's new liaison person with the Environment Committee of the European Parliament.
Member of European Parliament since 2009.
Current positions:
• ECR Group Coordinator for the Environment, Public Health and Food Safety Committee,
• Member of the Agriculture Committee,• Member of the Committee on Women's Rights and Gender Equality,• Member of the ASEAN Delegation for relations with South East Asia.
JULIE GIRLING
the quality of chemicals and prod-ucts and environmental protection that the citizens need,” Mrs Girling concludes.
© ECHA
18
news from echa
Croatia – a fast learning curveINTERVIEW BY PÄIVI JOKINIEMI
Croatia became a Member of the European Union in July 2013, but preparations for accession started years before that. ECHA News-letter spoke with Ms Dubravka Marija Kreković, the Senior State Sanitary Inspector at the Ministry of Health in Croatia, to hear how REACH is being enforced and how the cooperation with the Mem-ber States helped Croatia to adjust to the new legal framework.
“Before entering into the EU, we in-vested a lot of time in educating our inspectors so that they would be prepared for the new requirements and tools,” Ms Kreković explained. As part of these efforts, the inspec-tors were informed about the tools and guidance available after ac-cession to the EU. After joining the EU, they were also trained on how to access and use the information available in the REACH Information Portal for Enforcement (RIPE).
“We also prepared check lists to help our inspectors make sure that all necessary checks are carried out during the inspection. A separate check list was also prepared for required information in the safety data sheets (SDSs),” Ms Kreković says. Inspections do not only relate to REACH requirements but also check that companies comply with the CLP Regulation and have labelled their mixtures correctly.
SUPPORT RECEIVED PRIOR TO ACCESSION
Ms Kreković is very happy with the support that they received from ECHA and the EU Member States through the EU Instrument for Pre-accession Assistance (IPA) project. “For a small Member State, it is very important to see how other coun-tries have organised their activities. As a beneficiary of the IPA project, we had the opportunity to make study visits to EU Member States to see how their competent au-thorities and national enforcement authorities were working.”
The opportunity to create networks with other countries has been one
of the great advantages of the project. “We have had a lot of coop-eration, for example, with Slovenia and that has continued also after the IPA project. Slovenia is a small Member State just like Croatia and many of the challenges we face are similar,” Ms Kreković says. Getting to know colleagues from other Member States before entering into the EU has also made coopera-tion after accession easier.
“In addition to practical advice, we have also received good ideas and been able to create something of our own based on examples we have seen during our study visits,” Ms Kreković points out. At the moment, Croatia is developing its own IT based tool for inspections that will include for example, all regulations, check lists and documents from previous inspections. The idea for the tool came from one of the study visits in Germany. “The tool will be a great support for inspectors when they are in the field visiting compa-nies. We are using a lot of resources for this project and we hope to have the tool ready during spring 2015,” Ms Kreković says.
EDUCATING MICRO COMPANIES
One of the challenges for the Croatian enforcement authorities is the lack of resources, which affects the number of inspections that can be carried out each month. “So far since accession, we have carried out approximately 15 inspections a month on companies producing and importing chemicals. Down-stream users are also controlled,” Ms Kreković says and continues “however, if we receive a complaint
from a third party, we will make it our priority to get to the field and inspect the situation without delay.”
Problems identified during the inspections are often related to safety data sheets. “In Croatia, we have a lot of micro companies – many of them only having one or two employees. It is natural that there might be a lack of informa-tion and knowledge. Therefore, the first step in our work is to advise companies and tell them what they need to do to comply with the law,” Ms Kreković points out.
LEARNING THROUGH THE FORUM
Before accession, Croatia attended the meetings of the Enforcement Forum as an observer. This oppor-tunity made it easier for Croatia to plan how to develop their enforce-ment activities to ensure consist-ent enforcement across the EU.
Ms Kreković has since then been actively involved in the work of the Forum and during 2014 she chaired one of its working groups. “A lot of practical issues are discussed during the Forum meetings, which is very useful for all participants. We can see that we all deal with the same issues and we can get support and help from each other. It is great to have this big network of experts and inspectors,” she concludes.
Further information:
Instrument for Pre-accession Assistance (IPA)http://ec.europa.eu/enlargement/instru-ments/overview/index_en.htm
ECHA’s IPA activitieshttp://echa.europa.eu/international
Enforcement Forumhttp://echa.europa.eu/about-us/who-we-are/enforcement-forum
19
reach
ECHA has been helping a number of countries to prepare for Biocides, CLP, PIC and REACH since 2009: Albania, Bosnia and Herzegovina, Croatia, the former Yugoslav Republic of Macedonia, Kosovo*, Montenegro, Serbia and Turkey under the EU Instrument for Pre-accession Assistance (IPA).
* This designation is without preju-dice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.
DID YOU KNOW?
Cosmetics – to test or not to test?TEXT BY TIIU BRÄUTIGAM
The Cosmetics Regulation prohibits the sale of cosmetic products or ingredients which have been tested on animals. This ‘market-ing ban’ had created some uncertainty because the same chemical ingredients may need to be registered under REACH and may nor-mally have needed to be tested on animals in order to comply.
The European Commission, in coop-eration with ECHA, has clarified the relationship between the Cosmet-ics Regulation and the REACH information requirements:
• If substances are used exclusively in cosmetics, REACH registrants may not perform tests on animals in order to understand their impact on human health. The exception is where testing is needed in order to assess the risks of the substance to workers.
• If substances are used for many purposes, including cosmetics, registrants can perform animal testing. As always though, such testing must be a last resort.
• Registrants can test substances on animals, again as a last resort, for their environmental impact.
Therefore, the testing and market-ing ban in the Cosmetics Regulation
do not apply to testing required for environmental endpoints, exposure of workers and non-cosmetic uses of substances under REACH.
"The Commission became aware that there has been some confusion on the part of manufacturers and importers about the circumstances in which certain testing require-ments under REACH must be com-plied with,” explains a spokesperson from the Directorate-General for Enterprise and Industry.
“The interface between REACH and the Cosmetics Regulation has now been clarified. Manufacturers and importers can establish more easily when, despite the prohibitions in the Cosmetics Regulation, they may have to conduct animal testing as a last resort to comply with their REACH obligations. This clarifies registration requirements and con-
tributes to the REACH objective of replacing, reducing or refining animal testing where possible.”
ECHA has published Questions and Answers on its website and also a fact sheet on the relationship between REACH and the Cosmetics regulations.
Further information:
Animals used for scientific purposeshttp://ec.europa.eu/environment/chemi-cals/lab_animals/home_en.htm
REACH Information requirementshttp://echa.europa.eu/regulations/reach/substance-registration/information-requirements
REACH & Cosmetics – Q&Ahttp://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/cosmetics
Interface between REACH and Cosmetics regulations – Fact sheethttp://echa.europa.eu/publications/fact-sheets
ECHA's activities under the second IPA I project from 2012 to 2014.
© ECHA
20
news from echa
Improving ECHA's news products
Top five topics of the articles that the readers want to see in the Newsletter.Reader satisfaction with the online format of the Newsletter. The PDF version is also popular and continues to be available.
Each year, we ask for your feed-back on our news products. This year, we received over 2 000 responses – thank you! The sum-mary of the survey results is now available on our website.
WHAT YOU WANT TO READ ABOUT
Over 60 % of you want more stories on downstream user activities, authorisation and restriction, and classification and labelling. Other popular topics were REACH regis-tration 2018 and chemical safety assessment. It will be difficult to cover all topics in every issue but over the year we will aim to cover half of them in every issue.
As in 2013, practical examples from industry and best practice remain by far the most popular story types. Many of you would also like to continue reading Guest columns from experts. During 2014, almost a quarter of our articles were either Guest columns from experts or in-terviews with industry. In future, we are aiming to maintain this rate and increase it where possible.
SPECIAL ISSUE ON SUBSTITU-TION AND INNOVATION
In April 2014, we launched a special issue of the Newsletter focused on
substitution and innovation. 33 % of you said that the issue was somewhat helpful, 29 % said that it was helpful and 5 % said that it was very helpful. It seems that focus-ing on a single issue is not a high priority for you. Consequently, we will continue with our mixed content Newsletters.
RELIABLE E-NEWS CONTENT
The weekly e-News remains well ap-preciated. 87 % of you either agree or strongly agree that the content of the e-News is reliable and 83 % of you said that it is an efficient way of getting news from ECHA. 82 % of you either agree or strongly agree that the e-News is up-to-date and
81 % of you agree or strongly agree that the content is accurate. Thank you – we will continue in the same way for 2015 but aim for an even higher satisfaction next year.
BACKGROUND
Altogether, we received 2 332 re-sponses, which is over 1 000 more respondents than in 2013 and over 2 000 more than 2012.
Further information:
News readership 2014http://echa.europa.eu/about-us/the-way-we-work/plans-and-reports
TEXT BY PAUL TROUTH
The most popular story types among Newsletter readers.
© ECHA
© ECHA
© ECHA
