1 June2015

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3 Get your substance identity right – here's how

Identifying your substance is one of the first steps when preparing a registration dossier under REACH. Read what Stuart Niven, Senior Regulatory Affairs Manager at Harlan Laboratories Ltd considers as essential in building an accurate substance identity.

4 Downstream user experience: REACH is fundamental

ECHA Newsletter spoke with Richard Schreurs and Jos Bongers from SPGPrints to hear how REACH and CLP have affected their work and how the data generated is used in their company. REACH is some-thing that everyone in the company now knows as an integral part of their daily work.

7 Investor perspective: why REACH matters for your bottom line The guest column is from a group of Euro-pean investors, representing four invest-ment firms. They are looking for companies that are successfully investing in innova-tive, greener substitutes, which can take the lead in other regions and countries, where the chemical regulations are seeking to follow REACH.

16 How ECHA assesses your read-across

Read-across is the most commonly used alternative to testing chemicals on animals under REACH. The Read-Across Assess-ment Framework (RAAF) shows how ECHA assesses read-across in registration dossiers.

Does the REACH 2018 registration deadline affect you?

11 JUNE 2015annankatu 18, p.o. box 400, fi-00121 helsinki, finland | echa.europa.eu

Is your company one of the many that is preparing a REACH registration dossier for the first time? If you are, you can be happy – you have already overcome the first hurdle: you know that the 2018 deadline affects your company and you are starting early! To help you, we have broken down the registration process into seven phases that you need to go through for a successful registration. You can learn about them on our REACH 2018 web pages. They are a one-stop shop for all the available support material. Get familiar with the first phase – make sure you know your portfolio and understand what registration means for your company.

At this point, you need to consider which substances you want to have in your port-folio in the future. Listen to your customers and keep them informed of your inten-tions – the substances you put on the market may be critical for their business.

You also need to understand what information you need for your registration. This depends on the yearly volume of the substance that you manufacture or import and

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In this issue: 3 Get your substance identity right – here's how

4 Downstream user experience: REACH is fundamental

7 Investor perspective: why REACH matters for your bottom line

8 Better consumer protection through child-resistant packaging

10 RAPEX – keeping European consumers safe from chemical risks

12 Skin sensitisation – new methods to replace animal testing

14 Notifying the trade of hazardous chemicals more easily through ePIC

16 How ECHA assesses your read-across

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, Paul Trouth

European Chemicals AgencyAnnankatu 18, P.O. Box 400,FI-00121 Helsinki FinlandTel. +358 9 6861 80Fax +358 9 6861 8210

newsletter.echa.europa.euechanewsletter@echa.europa.euFollow @ EU_ECHALike us on Facebook Follow us on LinkedIn

“At this point, you need to consider

which substances you want to have

in your portfolio in the future.”

Director of RegistrationChristel Musset

Next issue of the News-letter will be

published in mid-September.

the way in which you use the substance. It is also good to start looking into the costs of registration. Your sector organisation is a good contact point for guidance on cost planning. Consider whether your company has the expertise it needs to manage the whole registration process. You may have all the knowledge you need in-house and feel that ECHA’s website and your national helpdesk are suffient support. However, if this is not the case, look for a good consultant who can help you with your registration. There are tips to help you online. Remember that you are not alone. Many companies have already success-fully registered their substances – and you will be able to do that too. At the end of this month, we will launch a further information package to help you with the questions and tasks of the first phase of registration. Finally, 31 May 2018 may seem far away, but there is a lot to do before you can get your registration number. The last registration deadline completes what started already in 2008: collecting information on all the chemicals in use on the European market. It is yet another important milestone towards the safer use of chemicals in Europe and you are an important part in mak-ing this happen!

REACH 2018 – who is it for?

• For companies that manufacture or import substances in low volumes, between 1-100 tonnes a year.

• For companies that have pre-registered their substances but have not yet registered them.

• More information at: http://echa.europa.eu/reach-2018

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Get your substance identity right – here's how

reach

INTERVIEW BY PÄIVI JOKINIEMI

Identifying your substance is one of the first steps you need to take when preparing a registra-tion dossier under REACH. ECHA Newsletter spoke with Dr Stuart Niven, Senior Regula-tory Affairs Manager at Harlan Laboratories Ltd, who gave a presentation on this topic at ECHA’s Stakeholders’ Day. Read his advice to small and medium sized enterprises and other REACH registrants on the key aspects in building an accurate substance identity.

Dr Niven, how would you advise SMEs or first time registrants to get started with their substance identity?

The key point is to start looking at the general class of the substance that you have, whether it is an organic, inorganic or oligomeric material. Try to get the basic idea of the substance and then tailor an appropriate analytics package with correct analytical techniques for the type of substance, taking into account the scope of substances covered in REACH and what needs to be registered. The analytical techniques can vary depending on the type of substance that you think you have. It is impor-tant to approach the analytics with full professionalism. Fully justify what you have, analyse properly, get the full identity package – only then do you really know what you have and can also justify to the authorities what you have.

Where can companies find help?

If all this sounds too complicated, you can always employ a consult-ant to give you some guidance. You could also employ a university to give you some help.

You can start discussions with your suppliers and with trade associa-tions who operate on your behalf. Remember that many aspects of analytics are confidential but trade associations often know how to bring these together in a non-confi-dential way.

The lead registrant for your sub-stance can also help and in many cases will have a substance identity profile. The SIEF is available and potentially substance consortia. There are many places to start.

There is also plenty of ECHA guid-ance available. You can also search online. I find the online databases, for example ChemSpider and SciFinder to be very useful. These cannot be used as a replacement for analytics performed on a reg-istrant’s substance itself. But they can help you with predictive tools for what your substance should look like within its spectral identity to give you some guidance if you are going in the right direction or not.

How much time should companies reserve for building an accurate substance identity?

This is a very difficult question to answer. A standard package, with a fairly easy substance, can take up to a month. However, laboratories

tend to be very busy. It could easily take another month of lead time before it can start and it may need further time to finalise reporting, particularly if you are using Good Laboratory Practice (GLP) which is required if you are doing further testing. So you could be looking at a three month package. Time may also be needed to prepare a suitable sample. For example, if the substance is supplied in a solvent, this may have to be removed if it is not considered part of the registra-tion substance. However, time is key and particular-ly so if something goes wrong. I am not talking about a test going wrong but rather the situation where your substance is not what you think it was. Or your substance is more complex, a UVCB (substance of unknown or variable composi-tion, complex reaction products or biological materials) rather than a

According to Dr Stuart Niven, a high-quality substance identity needs to have full traceability in addition to the quality of the actual test itself.

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communicating about safety

single substance; or something that requires a change in the analytical strategy or even additional tests. These can all take more time, in-cluding things like analytical devel-opment, for example, the substance may bind to the column of the High Performance Liquid Chromatogra-phy (HPLC) and require a complete new methodology.

So, start as soon as you can.

What do registrants need to keep in mind to build a high-quality substance identity?

Good quality testing. This means re-producible quality testing and also traceability. It’s no good simply hav-ing a spectrum that came from the manufacturer of the substance you have imported. You must be able to relate this back to your quality system, to batch numbers, and to the batch numbers of your suppliers so that you can go back through all of the stages of the manufacturing process. That to me is the key point. It needs to have full traceability in

addition to the quality of the actual test itself. If certain information is not included, you also need to justify that, and back it up with evidence.

Stuart Niven is the Head of Regula-tory Affairs Switzerland at Harlan, where he leads an expert consulting group in the preparation of dossiers for chemical, agrochemical, phar-maceutical, biocidal, food contact and cosmetics regulations. For the 2010 and 2013 REACH deadlines, he ran three consortia, had steering committee roles in 11 further consortia and acted as lead registrant for approximately 20 substances. The consortium groups in which he was involved registered more than 100 substances as lead.

Further information:

Stakeholders’ Day presentationshttp://echa.europa.eu/view-article/-/jour-nal_content/title/10th-stakeholders-day

Substance identityhttp://echa.europa.eu/regulations/reach/substance-identity

Questions and Answershttp://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/REACH/SubstanceI-dentification

REACH 2018http://echa.europa.eu/reach-2018

Substance Information Exhange Fora (SIEF) http://echa.europa.eu/regulations/reach/substance-registration/substance-infor-mation-exchange-fora

Guidance on REACHhttp://echa.europa.eu/guidance-docu-ments/guidance-on-reach

ChemSpiderhttp://www.chemspider.com/

SciFinderhttp://www.cas.org/products/scifinder

Terminology – in 23 languages http://echa-term.echa.europa.eu/

Downstream user experience: REACH is fundamentalINTERVIEW BY PÄIVI JOKINIEMI

ECHA Newsletter spoke with Richard Schreurs and Jos Bongers from SPGPrints to hear how REACH and CLP have af-fected their work and how the data generated is used in their company. REACH is something that everyone in the company now knows as an integral part of their daily work.

SPGPrints acts mainly as a down-stream user under REACH. This means that the company has not needed to register any substances themselves, but their uses have been covered by the registrations of their suppliers. According to Dr Schreurs and Mr Bongers, quite

many of the substances that SPG-Prints uses in their products and processes are due to be registered for the 2018 REACH registration deadline. Although this does not have a direct impact on the work-load of the company, the registra-tion intentions of their suppliers can make a big difference to their business.

KNOW WHAT SUBSTANCES WILL BE AVAILABLE ON THE MARKET

Whether to register a substance or remove it from the market is always a business decision that the sup-plier makes. This is something that every downstream user needs to consider. “Some chemicals are not available anymore or their composi-tion has changed. For example, a

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communicating about safety

Attitude of both the supplier and their customer is key when thinking of successful supply chain communication. From the left: Jos Bongers and Richard Schreurs.

product that we have used in our plating process is no longer avail-able. It has had a big impact on our work, because it took more than two years for us to find a good al-ternative,” says Mr Bongers, Safety, health and environment manager at SPGPrints.

Therefore, the first piece of advice that Dr Schreurs and Mr Bongers would like to give to other down-stream users is to be in a regular dialogue with their suppliers. “We have a system in place where we ask our suppliers if they can supply the substance during the next one, two or five years. If the substance in question is very critical to our business, we do this every year. However, the answer we get is of course only an indication, not a guarantee,” Mr Bongers highlights.

WHETHER TO SUBSTITUTE OR APPLY FOR AUTHORISATION

One of the biggest effects of REACH for SPGPrints has been the need to take a critical look at the substances that are used in their products and processes. As an example, they mention the use of chromium VI. “For some of our pro-cesses, we need to continue using chromium VI and that is why we are a member of the consortium that is preparing the authorisation dossi-ers,” Dr Schreurs, REACH Specialist at SPGPrints says. SPGPrints will not be applying for authorisation themselves, but their uses will be covered by their suppli-er’s application. Nonetheless, since the substance is very important for their processes, they decided to be part of the authorisation consor-tium from the beginning.

SPGPrints is applying for authori-sation for some uses of chromium VI while for others, they plan to substitute. “We have done a lot of research on alternatives. The decision on whether to apply for authorisation or to substitute is based on risk assessment and busi-

ness policy. We have some pilots ongoing to find suitable and safer alternatives and we think that we are on a good track,” Mr Bongers explains.

Both preparing the authorisation application and finding a suitable alternative takes a lot time and requires expertise. “For example, carrying out the socio-economic analysis is very difficult. Therefore, it is important to start early and ask for help from those who have the required expertise. This can be, for example, a consultant or your sector-association,” Dr Schreurs says.

IMPROVING SUPPLY CHAIN COMMUNICATION

To comply with REACH obligations, it is important that communication in the supply chain flows smoothly. According to Mr Bongers, the attitude of both the supplier and customer is key. It is about the real willingness to communicate openly, not just about stricter rules or ad-ditional paper work. It needs to be part of the company strategy and management philosophy. “We started communicating with our suppliers already years ago by sending them letters where we asked if they are planning to regis-ter the substances that we use. At the same time, we provided them with our uses and use descriptors,”

Dr Schreurs explains. SPGPrints’ experience of working in this way has been very positive.

“Sometimes we still notice insuf-ficient quality of information in the safety data sheets (SDSs). In those cases, we need to contact the sup-plier and ask for further explana-tions. This is particularly important for the product classification of our own formulated mixtures,” Mr Bongers says. Dr Schreurs adds that another challenge that the company regularly faces is the different format of the exposure scenarios received from different suppliers. This makes checking the content more time consuming.

Although the quality of safety data sheets is mixed, Dr Schreurs and Mr Bongers see that it has clearly improved since REACH came into force. This helps SPGPrints also in communicating accurate informa-tion to their customers.

INFORMATION FROM SAFETY DATA SHEETS USED FOR SEVERAL PURPOSES

“We receive the majority of data through the safety data sheets. We have an SDS authoring system in place to make sure that all of the information we receive gets dealt with systematically and can be eas-ily put into the safety data sheets that we in turn send to our custom-

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communicating about safety

Stork Prints was established in 1947, in Boxmeer in the Netherlands. In 2013, it changed its name to SPGPrints.

SPGPrints is a global leader in the textile and graphics printing market, of-fering rotary screen printing and digital printing solutions for printers and converters in the graphics and textile printing industries. The company also offers a variety of precision metal parts in the medical instruments, automotive, electronics, food, home appliances and process industries.www.spgprints.com

SPGPRINTS B.V.

ers,” Dr Schreurs explains. In prac-tice, this means that all information from the safety data sheets (reg-istration numbers, toxicity values, derived no-effect levels (DNELs) and predicted no-effect concentra-tions (PNECs)) are inserted into this internal system.

Systematically recording the information received as part of the SDSs also helps when fulfilling ob-ligations and applying for permits under other legislation. “There are several different pieces of legisla-tion that we need to comply with. There is the Chemicals Agents Directive (CAD), Carcinogens or Mutagens at Work Directive (CMD), Industrial Emissions Directive (IED), the Seveso Directive and the Water Framework Directive,” Dr Schreurs points out.

CHEMICAL MANAGEMENT SYSTEM IS A MUST

Dr Schreurs and Mr Bongers remind that all chemical companies should set up a management system to make sure their substances are dealt with in a systematic way and that all requirements under REACH are fulfilled. “We have created our own internal directive which is rolled out to all EU sites and it explains how they should comply with REACH,” Dr Schreurs says. The directive consists of six parts:

1. A chemical substance database in which all the incoming substances are included;

2. A mandatory procedure to check that newly purchased chemicals are not SVHCs, potential SVHCs or CMRs;

3. Template letters that can be used when communicating with suppliers and customers on REACH;

4. A part on safety data sheets and CLP, explaining how the sites should deal with incoming safety data sheets and check exposure scenarios as well as how the CLP symbols should be used;

5. A part on recognising SVHCs, considering applications for authorisation and substitution;

6. Instructions for an internal audit that is carried out on a yearly basis.

CUSTOMERS DEMANDING REACH-COMPLIANT PRODUCTS

Customer demand for safer prod-ucts has also put more pressure on downstream users. For SPGPrints, this is particularly the case with their inks. “We are often con-tacted by our customers who ask if our products are compliant with REACH and if any of the substances used in our products are on the Candidate List. This emphasises that we need to provide products that do not contain substances of very high concern,” Dr Schreurs explains. To make sure that the company can answer their customers’ demands, all new raw materials are checked to make sure that they are not carcinogenic, mutagenic or toxic to reproduction (CMR), substances of very high concern (SVHCs), (or with the potential to become one) before a purchasing decision is made. “Everyone in the company knows the procedure. Before buy-ing anything, they first have to look into the properties of the chemical product. For example, if a sub-stance turns out to be a CMR, they have to look for an alternative.” It is clear that REACH and CLP have resulted in both improvements and

more work – Mr Bongers mentions for example increased administra-tion and documentation, as well as costs. However, at the same time, these regulations have become a fundamental part of the business. “Previously, about three to four years ago, REACH didn’t live within our company as it does now. It is now accepted and everyone knows the concept of REACH,” Dr Schreurs concludes.

Dr Schreurs and Mr Bongers at-tended the Workshop on the use of REACH/CLP information at industrial sites that took place at ECHA in mid-April. See Dr Schreurs’ presentation “How a downstream user deals with REACH (and related chemical legislations)” from the event page.

http://echa.europa.eu/news-and-events/events/event-details/-/journal_con-tent/56_INSTANCE_DR2i/title/workshop-on-the-use-of-reach-clp-information-at-industrial-sites

Further information:

Downstream users and communication in the supply chainhttp://echa.europa.eu/regulations/reach/downstream-users

Who is a downstream user under REACH and CLP? (video)https://www.youtube.com/watch?v=eohk3JPjZhs&feature=youtu.be

REACH Authorisation http://echa.europa.eu/regulations/reach/authorisation

Terminology – in 23 languages http://echa-term.echa.europa.eu/

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people and perspectives

Guest column: Lisa Beauvilain, Seb Beloe, Helena Viñes Fiestas, Abigail Herron

We are a group of European investors, representing four investment firms with approximately €850bn of assets under management. We have different invest-ment approaches, some of us are smaller and specialise in sustainable investments, and some are much larger and offer broader mainstream investments.

Despite the differences of size and investment focus, we are all looking to invest in forward-looking compa-nies that are taking the initiative offered by the REACH Regulation. We want companies that are successfully investing in innovative, greener substitutes, which can take the lead in other regions and countries, where the chemical regulations are seeking to follow REACH.

Europe has been the uncontested global leader in chemical regulation since the start of REACH in 2007. REACH was not only introduced to ensure a high level of protection of human health and the environment but also to enhance competiveness and innovation in the European chemical sector. The regulation has indeed been closely followed and emulated by many other countries and regions since then.

It has enabled European chemical companies to in-novate and be ahead of chemicals regulation globally. Clear, predictable and long-term regulation is crucial for companies and investors in the chemical sector be-cause it provides investors with stability and direction. REACH has given a clear steer to European chemical companies to undertake R&D investments to develop sustainable chemical substitutes, thereby enhancing their long-term global competitiveness.

A critical part of the REACH framework is the au-thorisation process and in particular the restriction

of substances of very high concern (SVHCs) from the European market and their substitution with safer alternatives. Investors are consequently concerned by the recent European Commission proposal of ‘Stream-lining and simplification of the authorisation process for some specific cases’. This could have unintended and counter-productive effects on efforts by industry to in-vest in novel greener chemical products as substitutes, and certainly halts the clear and predictable signals for investors.

It is also important not to lose sight of the larger picture at a time of an “anti-red tape” and deregulatory sentiment in Europe. The UK Department of Energy and Climate Change (DECC) published a cost benefit analysis of 428 environmental laws and regulations in the UK in 2012; just over half from the EU. The analysis found that every £1 spent on compliance and enforce-ment of these rules returned on average £3 to society through economic, environmental and health benefits. Interestingly, the analysis showed that the greatest cost-benefits were related to regulations on chemicals; for every £1 spent, there were £18.90 worth of returns to society. As investors in the chemical sector, we closely follow the implementation of REACH and the use of SVHCs in companies. We also follow the outputs of investment researchers and NGOs who also provide valuable infor-mation about company SVHC exposures and potential substances for the Candidate List. Over the last years, we have been engaging with companies in the chemical sector to encourage them to improve their disclosure about chemicals. In particu-lar, we are keen to see chemical substance regulatory

Investor perspective: why REACH matters for your bottom line

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From left: Lisa Beauvilain, Seb Beloe, Helena Viñes Fiestas, Abigail Herron.

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exposures; the use of “intermediary” classifications; and company initiatives to substitute substances with lower toxicity alternatives.

A recent example is UK specialty chemical company Johnson Matthey plc. Since 2014 they have signifi-cantly strengthened their reporting of product stew-ardship, substitution and management of substances of concern. The company reports successful removal of cadmium from its brazing alloys, replacing it with a larger content of silver, but successfully bringing along the market, despite higher costs, through a campaign highlighting the health and safety risks of cadmium. The company also phased-out a lead compound pigment which was an SVHC. We have also seen several recent examples of companies phasing-out or substituting endocrine disrupting substances in anticipation of tightening EU definitions and regulation of endocrine disruptors.

To continue to see European chemical companies as global leaders in greener substance innovation and substitution, we need a continued strong implementa-tion of REACH. In our view, this will not only benefit the European chemical industry and investors over time, but society overall.

Lisa Beauvilain, Head of Sustainability & ESG, Impax Asset Management

Seb Beloe, Head of Sustainability Research, WHEB Asset Management

Helena Viñes Fiestas, Head of Sustainability Research, BNP Paribas Investment Partners

Abigail Herron, Head of Responsible Investment Engagement, Aviva Investors

Better consumer protection through child-resistant packagingTEXT BY PÄIVI JOKINIEMI

Packages containing hazardous substances or mixtures should not attract the curiosity of children and must be fastened in a way which makes it difficult for children to open them. This is specified in the Classification, Labelling and Packaging (CLP) Regulation.

Deficiencies in the packaging and fastening of products containing hazardous substances have been the cause of many accidents where children have been harmed. For example, in Sweden children are harmed by swallowing grill lighter fluids between 200 and 500 times every year.

According to the CLP Regulation, the design and shape of a package containing a hazardous substance or mixture must not attract the curiosity of children and should not mislead. This means that the package should not look similar to packaging used, for example, for foodstuffs or medicinal products. In addition, the regulation requires that products which contain certain hazardous substances and are sold

to the general public must have specific child-resistant fastening.

WHEN IS A CHILD-RESISTANT FASTENING REQUIRED?

The idea behind a child-resistant fastening is to make it more dif-ficult for children to open packages that contain hazardous substances. An example of a child-resistant fas-tening could be a cap that requires a certain level of coordination and the use of both hands to open. This is something that is difficult for a child but does not prevent an adult from using the product. A child-resistant fastening is required in all packages that are supplied to consumers and contain a substance or mixture with any of the following hazards:

• Acute toxicity in the highest categories (1-3): this means that the substance can cause poisoning after a single exposure. Products with this classification are usually not available to the general public but, for example, methanol-containing windscreen fluids, some antifouling products and some disinfectants for chemical toilets may be available to consumers and may have such an acute toxic effect.

• Toxicity to specific organs (STOT, category 1): this means that the substance can cause damage to certain organs, such as the liver or the lungs. Certain substances can have this harmful effect already after single exposure; with other substances repeated exposure is needed. For instance, varnishes can contain substances that are toxic to specific organs.

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ECHA's Forum of Enforcement Authorities is kicking off a project focus-ing on the safe packaging of consumer products requiring child-resistant fastening. Typical examples of such products with child-resistant fasten-ings are grill lighter fluids, disinfectants, cleaning and laundry products as well as drain unblockers. Inspectors in 15 Member States will target companies – from manufac-turers to retailers – to check that products supplied to the general public meet the requirements.

The inspections will run from July to December 2015 and a final report will be published in June 2016.

ENFORCING PACKAGING REQUIREMENTS

• Skin corrosion: this means that the substance can cause severe skin burns and eye damage. For example, drain unblockers and toilet cleaners may contain substances with this classification.

• Aspiration hazard: this means that after swallowing, the chemical enters the airways and can cause severe acute effects in the lungs, such as chemical pneumonia, varying degrees of pulmonary injury or even death. Products that contain volatile hydrocarbons, such as turpentine or grill lighter fluids, are classified for aspiration hazard.

Additionally, if a product contains methanol in a concentration of at least 3% or dichloromethane in a concentration of at least 1%, the package must have a child-resistant fastening. The use of both sub-stances in consumer products in the EU has greatly decreased, but they may, for example, still be present in antifreeze products (methanol) and certain adhesives (dichlorometh-ane).

PACKAGING OF LIQUID LAUNDRY DETERGENTS

In recent years, liquid laundry de-tergents in soluble packaging have been the focus of additional at-tention because of their increased sales on the EU market. With their growing popularity, the number of severe incidents of poisoning and eye damage to children has also increased. At the end of 2014, the CLP Regula-tion was amended to clarify the rules on the labelling and packag-ing of liquid laundry detergents in soluble packaging, to make sure that consumers know the risks of the products and get sufficient protection.

From 1 June 2015, liquid consumer laundry detergent capsules must be more resistant to pressure, must

not dissolve too quickly and must contain a flavouring agent that causes a repulsive effect if a child puts the capsule in their mouth. The outer packaging of the single-use capsules must be opaque to make it more difficult for children to see the individual capsules inside. The outer packaging needs to be so designed that coordinated action of both hands is required to open the package. In addition, the precau-tionary statement “Keep out of reach of children” must be visibly printed on the outer packaging.

Further information:

Commission Regulation (EU) No 1297/2014http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R1297&from=EN

CLP pictogramshttp://echa.europa.eu/chemicals-in-our-life/clp-pictograms

Specific labelling and packaging situationshttp://echa.europa.eu/regulations/clp/la-belling/specific-labelling-and-packaging-situations

C&L Inventoryhttp://echa.europa.eu/regulations/clp/cl-inventory

CLP quiz http://echa.europa.eu/clp-quiz

The first pictogram on the left relates to acute toxicity, the one in the middle to toxicity to specific organs as well as to aspiration hazard and the one on the right to skin corrosion.

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people and perspectives

RAPEX – keeping European consumers safe from chemical risksTEXT BY VIRGINIA MERCOURI

The variety of products traded across national borders is growing every day. To make sure that consumers are safe, national authori-ties in the EU Member States, Iceland, Liechtenstein and Norway are on alert. They coordinate their enforcement actions through the EU’s Rapid Exchange System for information on dangerous non-food products – RAPEX.

RAPEX has been in place since 2003 and the number of risks com-municated through the system has grown every year. In 2014, nearly 2 500 notifications about unsafe products breaching EU laws and standards were made through RAPEX.

When a dangerous non-food prod-uct (other than a pharmaceutical or medical device) is withdrawn from the market or recalled, the Euro-pean Commission and the other national authorities are quickly alerted through RAPEX about the need to take action. As a result, products intended for consumer or professional use that can cause serious health, safety or environmental risks can be stopped from reaching other countries, re-moved from the market or recalled from consumers who have already bought them.

CHEMICAL RISKS IN CONSUMER PRODUCTS

Around one quarter of all notifica-tions sent through RAPEX have been about the presence of chemi-cals in consumer products. The most common chemical risks in 2014 were:• for toys and childcare articles

containing phthalates that may cause fertility problems;

• for shoes and leather articles which had high levels of the skin sensitising substance chromium VI; and

• for jewellery containing harmful heavy metals, like cadmium, lead and nickel.

All these substances are either banned or restricted under REACH for the uses mentioned. Two joint actions of the national market surveillance authorities focused on chemicals in clothes – one in 2010 for children’s fancy dress and a wider one in 2014. One hundred and forty nine samples of textiles were gathered in 2014 and around 10% of the sampled products were found to be unsafe. For all of them, the reason was non-compliance with the REACH restrictions for chromium VI, or be-cause they contained carcinogenic azodyes or phthalates.

DANGEROUS PRODUCT IMPORTS

The overwhelming majority of unsafe products found on the EU market are coming from outside the EU and nearly two thirds from China, which has the biggest share of EU imports. REACH bans the use of DEHP in toys and childcare articles in concentrations greater than 0.1%. However, high concentrations of this plasticiser are frequently detected in imported toys. One ex-ample is a doll imported from China which contained the plasticiser DEHP in a concentration of 38.5 % by weight. Since the launch of the

rapid alert system, more than 1 200 notifications involving the unauthorised presence of DEHP have been made, the overwhelming majority related to toys.

To enhance the effectiveness of controls, there is now stronger col-laboration between market sur-veillance authorities and customs authorities. Relevant information from RAPEX is regularly trans-ferred to the EU wide customs risk management system, which uses common risk selection criteria for controls and the computerised exchange of information on move-ment of goods. As a result, customs authorities are able to better target their controls and stop dangerous products directly at the EU borders.

RAPEX AND REACH

RAPEX has also contributed to the REACH process of restricting dangerous substances in consumer articles. One example is imported sofas that were treated with the anti-mould chemical dimethylfuma-rate (DMFu) to keep the leather dry. This caused serious skin burns and injuries, leading to costly product recalls and an EU-wide emergency ban.

© EUROPEAN COMMISSION

RAPEX stands for the EU’s Rapid Exchange System for information on dangerous non-food products.

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people and perspectives

The recurrent RAPEX notifica-tions about products containing DMFu contributed to a permanent restriction under REACH of articles containing DMFu in concentra-tions greater than 0.1%. Since the restriction came into force in 2012, the number of RAPEX notifications on DMFu has gone down signifi-cantly.

BUSINESS RESPONSIBILITIES

The General Product Safety Direc-tive, which governs RAPEX, requires importers and distributors to take immediate measures when a product is identified as dangerous: they need to report the risk and the measures taken to eliminate it; withdraw the product from the mar-ket; inform consumers and tell them what steps they have to take. Importers and retailers can avoid purchasing and selling dangerous

products and decrease the risks for potentially costly product recalls. Monitoring RAPEX can help.

Further information:

REACH restricted substances http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions

REACH restrictions under considerationhttp://echa.europa.eu/restrictions-under-consideration

Forum for exchange of information on enforcementhttp://echa.europa.eu/about-us/who-we-are/enforcement-forum

The joint action on chemicals in clothinghttp://www.prosafe.org/index.php?option=com_content&view=article&id=129:chemicals-in-clothing&catid=53:2013&Itemid=607

In 2014, one in every four RAPEX alerts was about serious chemical risks in consumer products.

Each RAPEX entry has a detailed description of the product, a picture and includes the product model number and batch number/bar code. The risks of the product are presented with clear references to the EU standards for consumer safety. The database can be filtered by product category, name, brand and type/level of risk, year of notification or country. The RAPEX pages are updated every Friday and it is possible to subscribe for email alerts or RSS feeds.

http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex

MAKING SEARCHES IN RAPEX

HOW IS RAPEX USED?

“RAPEX is an important tool for consumer organisations. It is widely used to monitor the level of prod-uct safety in the EU and to encour-age more product testing. However, RAPEX has an untapped potential. We want to see it further strength-ened as an effective enforcement tool”.

Sylvia Maurer, Head of Sustain-ability and Safety at the European Consumer Organisation BEUC

* * * * * * *

“The fourth joint REACH Enforce-ment Project in 2016 will focus on REACH restrictions. One of the reasons to select this topic was that various RAPEX notifications from different Member States are related to consumer articles which are covered by REACH restrictions. There is increased interest in their harmonised enforcement. Further-more, the number of RAPEX notifi-cations also plays a role in helping select which restrictions and which types of articles to check”.

Dr Szilvia Deim, Deputy Director General of the National Public Health Center, Hungary, and Chair of ECHA's Enforcement Forum

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Skin sensitisation – new methods to replace animal testingINTERVIEW BY TIIU BRÄUTIGAM

All substances registered under REACH need to contain infor-mation on their skin sensitisa-tion potential. Silvia Casati, Senior scientific officer from the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM) at the European Commission’s Joint Research Centre (JRC) tells ECHA Newsletter about some new methods that can be used to replace animal testing in many REACH registrations.

In the last 10 years, there has been great progress in developing non-animal test methods. These methods include for example in vitro tests using cells or tissues and in silico methods using computer-based models. “I see two factors behind this development: a better understanding of the biology behind the adverse effects of substances and the changes in the European regulatory framework,” Ms Casati explains.

She mentions two pieces of Euro-pean legislation that have promoted the development of alternatives to testing on animals: the Cosmetics Regulation with its ban on animal testing, and REACH in promoting the use of alternative methods and having animal testing only as a last resort. For ECVAM, REACH has been the primary driver for validat-ing new alternative test methods in recent years. “A recent example of REACH encouraging the use of alternative test methods is related to skin cor-rosion/irritation and to serious eye damage/eye irritation. The availabil-ity of scientifically valid alternative methods that have been accepted by the regulators has resulted in a much greater use of in vitro data by registrants,” she points out.

ALTERNATIVE METHODS TO BE USED IN COMBINATION

Ms Casati highlights that we now have a variety of alternative meth-ods, addressing the biological and chemical mechanisms of skin sen-sitisation. However, none of these methods can currently be used in isolation. “They don’t predict the final effect, but provide information on spe-cific mechanisms, underlining the adverse effect. The challenge is to understand how to use these al-ternative methods in combination, so that the information is accurate enough to be used for regulatory purposes,” she says.

NEW METHODS ON THE WAY

To help registrants identify the relevant alternative test methods, ECHA and the EURL-ECVAM have been working together on new test guidelines for skin sensitisation which were recently adopted by the OECD.

“These in vitro and in chemico methods address key mechanisms of the skin sensitisation pathway. Advice on how to use the methods

is already available for REACH reg-istrants. Additionally, we at EURL-ECVAM have validated a third new in vitro method called the human cell line activation test (h-CLAT). The draft test guideline is currently being discussed in the OECD,” Ms Casati says.

EURL-ECVAM is also evaluating a variety of other methods from research laboratories and industry.

Anyone interested in these up-coming alternative test methods can follow their progress with the Tracking System for Alternative test methods towards Regulatory Acceptance (TSAR) provided by the JRC. “TSAR shows how an alterna-tive method progresses from a proposal for validation through to its final adoption into the regula-tory framework at the OECD and EU level,” she adds.

TSAR is currently being updated to give more comprehensive tracking information through a user-friendly web interface. The updated system will also track test methods that are under evaluation by other interna-tional validation centres. Its public release is planned for autumn 2015.

Registrants should get familiar with the advice on how to use alternative methods instead of testing on animals.

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REDUCING ANIMAL TESTS FOR THE REACH 2018 DEADLINE

Ms Casati clarifies that a complete replacement of all animal tests for assessing skin sensitisation will be hard to achieve. “There will still be cases where the alterna-tive methods might not give all the relevant information. For example, the potency of the sensitiser still remains a problem. It is key for risk and safety assessment, but we still need time to understand how in vitro methods could predict potency,” she says.

For many chemicals, however, non-animal test methods are very relevant for the 2018 registration deadline. With the new guidelines, an increase in the use of in vitro data for dossiers, even before 2018, can be expected. “Most of the alternative test methods are designed for hazard identification, which is relevant for a large number of REACH registrants. In terms of scientific progress in hazard iden-tification, we are almost there,” she highlights.

Ms Casati is also confident that new methods, currently under develop-ment, might overcome some of the existing limitations in the near fu-ture. The information that the new alternative methods provide needs to be used well and interpreted in

ECHA has published advice on using the new OECD test guidelines on skin sensitisation. The new non-animal test guidelines each address a specific key event in the adverse outcome pathway for skin sensitisation, describ-ing the main biological steps. They are relevant for many registrants pre-paring for the 2018 REACH registration deadline and, if used correctly, can replace the need to use animal test methods.

The adopted OECD test guidelines are: • 442C: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay

(DPRA), and • 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method

(KeratinosensTM).

The draft OECD test guideline is:• In Vitro human cell line activation test (h-CLAT).

http://echa.europa.eu/support/oecd-eu-test-guidelines

a rational way. “With the existing methods available, it is now up to the registrant to build a well-thought case, based on the guid-ance and advice provided. Then it is also up to the regulators to decide whether the registrants’ arguments are convincing,” she concludes.

DEFINITIONS

In vitro: Studies using cells, tissues or organs in glass or plastic vessels in the laboratory.

In vivo: Test conducted on a living organism.

In chemico: The use of abiotic (non-animal or in vitro) measurements of the reactivity or other physico-chemical properties of compounds.

In silico: Test which is done or pro-duced by using computer software or simulation, for example, QSARs.

Further information:

Flash report from the workshop on Alternatives for Skin sensitisation testing and assessment (23-24 April 2015)http://cefic-lri.org/events/joint-cross-sector-workshop-on-alternatives-for-skin-sensitization-testing-and-assess-ment/

NEW OECD TEST GUIDELINES AVAILABLE

DID YOU KNOW?

The European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM) was established in 2011.

Research laboratories can submit alternative methods that they have developed to EURL-ECVAM for scientific validation. EURL-ECVAM also promotes the development and dissemination of alternative methods and approaches, their application in industry and their acceptance by regulators.

https://eurl-ecvam.jrc.ec.europa.eu/

The Tracking System for Alternative test methods towards Regulatory acceptance (TSAR) http://tsar.jrc.ec.europa.eu/

Factsheet – Role of Animal Testing in ensuring the Safe use of Chemical Substances http://echa.europa.eu/publications/fact-sheets

Terminology – in 23 languages http://echa-term.echa.europa.eu/

© ECHA

According to Silvia Casati, the availability of scientifically valid alternative methods that have been accepted by the regulators has resulted in a much greater use of in vitro data by registrants.

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Notifying the trade of hazardous chemicals more easily through ePICINTERVIEW BY PAUL TROUTH

In the first quarter of each year, exporters and importers of haz-ardous chemicals subject to the Prior Informed Concern (PIC) Regulation have to inform their designated national authorities (DNAs) about the amounts they have shipped to or from each non-EU country during the previous year. This year is the first time that the reporting has been managed electronically as it is now integrated into ePIC. ECHA Newsletter spoke to Dr Marco Pirinoli and Ms Alberta Sbarufatti at the Italian com-pany, Novafito S.p.A., to ask how they have adapted to ePIC.

Novafito S.p.A.’s main activities relate to the export and distribu-tion of agrochemical products and recycled plastics. They trade in Italy and export throughout Europe and around the world. “For some of our products, we need an export authorisation and an im-port authorisation from the import-ing country,” Dr Pirinoli informs.

THE IMPACT OF PIC ON COMPANIES

As a small company with only six employees, Dr Pirinoli and Ms Sbarufatti are the only staff that work on PIC. “In the beginning, PIC seemed very difficult for a company of our size and we found ePIC to be a little complicated,” Dr Pirinoli says. “However, once we started us-ing it, we were able to overcome our difficulties,” he tells.

In Dr Pirinoli’s view, the size of their company hasn’t really affected their ability to comply with PIC. “If we compare ourselves to an Italian multinational, they clearly have

more resources and staff that can be dedicated to the PIC work. How-ever, they are also likely to have more products affected by PIC than we do,” he says. “Of course, while the multinationals can hire employ-ees who are solely dedicated to PIC, this is a luxury that we don’t have as we also have to manage many other activities aside from PIC. For me, it is all about managing our time well,” Dr Pirinoli continues.

LEARNING TO USE EPIC

“In the past, we didn’t use EDEXIM to notify ourselves because our notifications were done as part of a joint venture with an agroscience group. This is the first time that we have submitted our export noti-fications by ourselves and so we needed to learn how the ePIC sys-tem worked,” says Ms Sbarufatti.

Aside from their own notifications, Novafito S.p.A. has also submitted export notifications on behalf of another Italian company, Finchim-ica. Finchimica is an independent company, but belongs to the same group, Finagro S.p.A. For Ms Sbarufatti, it was relatively easy to learn how to use ePIC. “It is not a complex tool and we were

able to quickly learn to use it to sub-mit our notifications. The good thing is that when we ran into some issues with the tool or had some doubts, we were able to contact ECHA and resolve them very quickly,” she adds.

“We are very happy with the speed and quality of the support of-fered by ECHA. Getting a response quickly is really important for us as it helps us to conduct our PIC activities efficiently and manage our business well. Sometimes, wait-ing for a response from the national authorities can take time and this is something we think needs to im-prove,” Ms Sbarufatti highlights.

In the January release of ePIC, a new feature was added which stores the company names and addresses of importers, making it easier to re-trieve these details without having to input them manually.

NOTIFYING ELECTRONICALLY

Novafito S.p.A. sees the new system of reporting electronically as a posi-tive development. The previous tool, EDEXIM, did not allow this report-ing obligation which was therefore managed outside the system.

Having the whole reporting process now in ePIC makes it more efficient and less error-prone. From the left: Marco Pirinoli and Alberta Sbarufatti.

© MARCO PIRINOLI © ALBERTA SBARUFATTI

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“Moving the reporting to an elec-tronic system is clearly beneficial. It has cut down the workload because Excel is no longer used to report the numbers of exports manually. Now, all of the amounts are already prefilled in the system from the no-tifications that were submitted last year. We only need to check them and send them to the authorities us-ing ePIC,” Ms Sbarufatti confirms.

Since companies report to the au-thorities in ePIC and authorities use the same system to report to the European Commission, the whole reporting process is in one place which makes it more efficient and less error-prone.

THE NEED FOR CONTINUED SUPPORT

In 2014, Novafito S.p.A. attended two workshops on ePIC in Helsinki. “They gave us a chance to work specifically on simulations for our export notifications. We learned a lot because we were able to look at our situation side-by-side with ECHA. This made it easier to work on the tool when we returned back to our offices in Italy,” Dr Pirinoli remarks.

Novafito S.p.A. then shared their knowledge with other companies. “After the first workshop in May, we were contacted by another Italian company that was having difficulties using ePIC. They were not able to attend the workshops themselves, and so they were ask-ing for our support in using the tool. We were happy to help them and did so by following the examples we had received at the workshop,” Dr Pirinoli explains.

“I think that this experience shows that there is still a need to reach out to some companies who may be struggling with PIC. I really hope that such workshops will also be held in the future,” Dr Pirinoli concludes.

Further information:

PIC Regulationhttp://echa.europa.eu/regulations/prior-informed-consent-regulation

Export notification procedure http://echa.europa.eu/regulations/prior-informed-consent/export-notification-procedure

Annual reporting on PIC chemicalshttp://echa.europa.eu/regulations/prior-informed-consent/annual-reporting-on-pic-exports-and-imports

Guidance on PIChttp://echa.europa.eu/regulations/prior-informed-consent/understanding-pic

ePIChttp://echa.europa.eu/support/dossier-submission-tools/epic

Novafito S.p.A. is an independent commercial company specialised in the sale of agrochemical products. Belonging to the Italian group Finagro S.p.A., they are based in the outskirts of Milan. They have sales activity worldwide, with their main export activities in the EU, United States, Bra-zil, Australia as well as some Middle-East, Far-East and African countries. Novafito’s products are mainly herbicides, but they also have some other types of agrochemicals, such as fungicides and insecticides and other fine chemical intermediates in their portfolio.

NOVAFITO S.P.A.

DID YOU KNOW?

Export notifications for 2015

4 685 notifications for exports in 2015 have been approved by ECHA and the DNAs by the end of May 2015. Only the first yearly export of a chemical/mixture/article to each importing country needs to be notified.

Reported export and import of PIC chemicals during 2014

By the end of May 2015:

125 companies reported imports of PIC chemicals.400 companies reported exports of PIC chemicals.

The legal deadline for submitting these reports has passed and they can no longer be submitted through ePIC. Those companies who have not submitted their reports yet must contact their DNAs as soon as possible.

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How ECHA assesses your read-acrossTEXT BY TIIU BRÄUTIGAM

experts to improve their explana-tions of why and how read-across can be used in dossiers.

CONSISTENCY

The RAAF structures the scien-tific evaluation of read-across approaches: it directs and guides ECHA’s scientific experts by posing relevant questions and providing possible answers. Applying the RAAF will result in a structured assessment of the strengths and weaknesses of the read-across. Using the RAAF will also make sure that ECHA consistently identifies possible shortcomings in the docu-mentation, scientific reasoning or supporting evidence. The outcome of ECHA’s assessment will be a con-clusion on whether the read-across is scientifically acceptable or not.

ECHA is planning an update to the RAAF next year to cover environ-mental endpoints.

ASSESSMENT THROUGH SCENARIOS Read-across approaches are as-sessed using six different scenari-os and their respective assessment

elements and assessment options. The scenarios describe different grouping and read-across ap-proaches. Each scenario has several assess-ment elements which are crucial when judging how valid and reliable a read-across is. The assessment elements contain detailed expla-nations and examples. For each assessment element, an assessor is guided through a series of ques-tions to select the most appropri-ate assessment option.

Further information:

Grouping of substances and read-acrosshttp://echa.europa.eu/support/grouping-of-substances-and-read-across

Information toolkithttp://echa.europa.eu/support/informa-tion-toolkit

Factsheet – Role of Animal Testing in ensuring the Safe use of Chemical Substances http://echa.europa.eu/publications/fact-sheets

Terminology – in 23 languages http://echa-term.echa.europa.eu/

Read-across enables a registrant to use information from a known substance to predict properties for their substance. A large majority of registrants used read-across for the 2010 and 2013 deadlines. When used correctly, it can help to avoid unnecessary testing on vertebrate animals.

The Read-Across Assessment Framework (RAAF) provides a structured approach to the sci-entific evaluation of read-across justifications in registration dos-siers. The first part covers read-across of human health endpoints for mono-constituent substances. ECHA is using it to make sure that read-across cases for human health endpoints are assessed consist-ently during dossier evaluation.

The RAAF does not replace the official guidance on read-across for registrants but complements it by showing how ECHA assesses read-across cases.

REGISTRANTS: USE IT TO IMPROVE YOUR READ-ACROSS

Read-across is a complex process and needs specific toxicological expertise.

Registrants’ experts can use the RAAF to see the aspects of read-across justifications that ECHA considers to be crucial. This should help them to assess the quality of their own read-across cases and to anticipate how ECHA will assess them. Hopefully, this will enable the

Read-across is the most com-monly used alternative to test-ing chemicals on animals under REACH. The Read-Across As-sessment Framework (RAAF) shows how ECHA assesses read-across in registration dos-siers.

The RAAF structures the scientific evaluation of read-across approaches: it directs and guides ECHA’s scientific experts by posing questions and providing possible answers.

© FOTOLIA