1. No category

3
1
June
2015
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 something that everyone in the company now
knows as an integral part of their daily
work.
Does the REACH 2018 registration
deadline affect you?
7 Investor perspective:
why REACH matters for
your bottom line
The guest column is from a group of European investors, representing four investment firms. They are looking for 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.
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 Assessment Framework (RAAF) shows how ECHA
assesses read-across in registration
dossiers.
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 portfolio in the future. Listen to your customers and keep them informed of your intentions – 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

annankatu
18 ,
p.o. box
400,
fi - 00121 helsinki, finland | echa.europa.eu
11 JUNE 2015
2
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.
© ECHA
Consider whether your company has the expertise it needs to manage the
whole registration process. You may have all the knowledge you need inhouse 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 successfully 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 making 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
Christel Musset
Director of Registration
“At this point, you
need to consider
which substances
you want to have
in your portfolio in
the future.”
yet registered them.
Next issue
of the Newsletter will be
published in midSeptember.
• More information at: http://echa.europa.eu/reach-2018
In this issue:
3
4
7
8
10 12 14
16
Get your substance identity right – here's how
Downstream user experience: REACH is fundamental
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.
Investor perspective: why REACH matters for your bottom line
ISSN: 1831-4953
Better consumer protection through child-resistant packaging
Editor-in-chief: Lindsay Jackson
Editors: Päivi Jokiniemi,
Hanna-Kaisa Torkkeli, Paul Trouth
RAPEX – keeping European consumers safe from chemical risks
Skin sensitisation – new methods to replace animal testing
Notifying the trade of hazardous chemicals more easily through ePIC
How ECHA assesses your read-across
European Chemicals Agency
Annankatu 18, P.O. Box 400,
FI-00121 Helsinki Finland
Tel. +358 9 6861 80
Fax +358 9 6861 8210
newsletter.echa.europa.eu
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3
Get your substance identity right – here's how
INTERVIEW BY PÄIVI JOKINIEMI
Identifying your substance is
one of the first steps you need to
take when preparing a registration dossier under REACH.
ECHA Newsletter spoke with
Dr Stuart Niven, Senior Regulatory 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 important 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?
© ECHA
If all this sounds too complicated,
you can always employ a consultant 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 associations 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-confidential way.
The lead registrant for your substance 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 guidance 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 registrant’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
According to Dr Stuart Niven, a highquality substance identity needs to have full
traceability in addition to the quality of the
actual test itself.
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 registration substance.
However, time is key and particularly 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 composition, complex reaction products or
biological materials) rather than a

reach
4
single substance; or something that
requires a change in the analytical
strategy or even additional tests.
These can all take more time, including things like analytical development, for example, the substance
may bind to the column of the High
Performance Liquid Chromatography (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 reproducible quality testing and also
traceability. It’s no good simply having 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 Regulatory Affairs Switzerland at Harlan,
where he leads an expert consulting
group in the preparation of dossiers
for chemical, agrochemical, pharmaceutical, 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 presentations
http://echa.europa.eu/view-article/-/journal_content/title/10th-stakeholders-day
Substance identity
http://echa.europa.eu/regulations/reach/
substance-identity
Questions and Answers
http://echa.europa.eu/qa-display/-/
qadisplay/5s1R/view/REACH/SubstanceIdentification
REACH 2018
http://echa.europa.eu/reach-2018
Substance Information Exhange
Fora (SIEF)
http://echa.europa.eu/regulations/reach/
substance-registration/substance-information-exchange-fora
Guidance on REACH
http://echa.europa.eu/guidance-documents/guidance-on-reach
ChemSpider
http://www.chemspider.com/
SciFinder
http://www.cas.org/products/scifinder
Terminology – in 23 languages
http://echa-term.echa.europa.eu/
Downstream user experience: REACH is
fundamental
INTERVIEW BY PÄIVI JOKINIEMI
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 something
that everyone in the company
now knows as an integral part
of their daily work.
SPGPrints acts mainly as a downstream 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 SPGPrints 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 workload of the company, the registration intentions of their suppliers
can make a big difference to their
business.
communicating about safety
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 supplier makes. This is something that
every downstream user needs to
consider. “Some chemicals are not
available anymore or their composition has changed. For example, a
5
product that we have used in our
plating process is no longer available. It has had a big impact on our
work, because it took more than
two years for us to find a good alternative,” 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 downstream 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 processes, we need to continue using
chromium VI and that is why we are
a member of the consortium that is
preparing the authorisation dossiers,” Dr Schreurs, REACH Specialist
at SPGPrints says.
SPGPrints will not be applying for
authorisation themselves, but their
uses will be covered by their supplier’s application. Nonetheless, since
the substance is very important for
their processes, they decided to be
part of the authorisation consortium from the beginning.
SPGPrints is applying for authorisation 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-
© ECHA
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.
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 additional 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 register the substances that we use. At
the same time, we provided them
with our uses and use descriptors,”
communicating about safety
Dr Schreurs explains. SPGPrints’
experience of working in this way
has been very positive.
“Sometimes we still notice insufficient quality of information in the
safety data sheets (SDSs). In those
cases, we need to contact the supplier and ask for further explanations. 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 information 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 easily put into the safety data sheets
that we in turn send to our custom-

6
ers,” Dr Schreurs explains. In practice, this means that all information
from the safety data sheets (registration numbers, toxicity values,
derived no-effect levels (DNELs)
and predicted no-effect concentrations (PNECs)) are inserted into this
internal system.
Systematically recording the
information received as part of the
SDSs also helps when fulfilling obligations and applying for permits
under other legislation. “There are
several different pieces of legislation 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 products has also put more pressure on
downstream users. For SPGPrints,
this is particularly the case with
their inks. “We are often contacted 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 buying anything, they first have to look
into the properties of the chemical
product. For example, if a substance 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 administration 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 attended 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_content/56_INSTANCE_DR2i/title/workshopon-the-use-of-reach-clp-information-atindustrial-sites
Further information:
Downstream users and
communication in the supply chain
http://echa.europa.eu/regulations/reach/
downstream-users
Who is a downstream user under
REACH and CLP? (video)
https://www.youtube.com/watch?v=eohk
3JPjZhs&feature=youtu.be
REACH Authorisation
http://echa.europa.eu/regulations/reach/
authorisation
Terminology – in 23 languages
http://echa-term.echa.europa.eu/
SPGPRINTS B.V.
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, offering 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
communicating about safety
7
Guest column: Lisa Beauvilain, Seb Beloe, Helena Viñes Fiestas,
Abigail Herron
Investor perspective: why REACH matters for
your bottom line
Despite the differences of size and investment focus,
we are all looking to invest in forward-looking companies 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 innovate and be ahead of chemicals regulation globally.
Clear, predictable and long-term regulation is crucial
for companies and investors in the chemical sector because 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.
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 enforcement 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 information 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 particular, we are keen to see chemical substance regulatory
© BNP PARIBAS INVESTMENT PARTNERS
© WHEB ASSET MANAGEMENT
© IMPAX ASSET MANAGEMENT
A critical part of the REACH framework is the authorisation 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 ‘Streamlining and simplification of the authorisation process
for some specific cases’. This could have unintended and
counter-productive effects on efforts by industry to invest in novel greener chemical products as substitutes,
and certainly halts the clear and predictable signals for
investors.
From left: Lisa Beauvilain, Seb Beloe, Helena Viñes Fiestas, Abigail Herron.
people and perspectives
© AVIVA INVESTORS
We are a group of European investors, representing
four investment firms with approximately €850bn of
assets under management. We have different investment approaches, some of us are smaller and specialise
in sustainable investments, and some are much larger
and offer broader mainstream investments.

8
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 significantly strengthened their reporting of product stewardship, 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 implementation 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 packaging
TEXT 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 difficult for children to open packages
that contain hazardous substances.
An example of a child-resistant fastening 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:
clp
• 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.
9
• Skin corrosion: this means
© ECHA
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 substances in consumer products in the
EU has greatly decreased, but they
may, for example, still be present in
antifreeze products (methanol) and
certain adhesives (dichloromethane).
PACKAGING OF LIQUID
LAUNDRY DETERGENTS
In recent years, liquid laundry detergents in soluble packaging have
been the focus of additional attention 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 Regulation was amended to clarify the
rules on the labelling and packaging 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
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.
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 precautionary statement “Keep out of
reach of children” must be visibly
printed on the outer packaging.
CLP pictograms
http://echa.europa.eu/chemicals-in-ourlife/clp-pictograms
Specific labelling and packaging
situations
http://echa.europa.eu/regulations/clp/labelling/specific-labelling-and-packagingsituations
C&L Inventory
http://echa.europa.eu/regulations/clp/
cl-inventory
CLP quiz
http://echa.europa.eu/clp-quiz
Further information:
Commission Regulation (EU) No
1297/2014
http://eur-lex.europa.eu/legal-content/
EN/TXT/PDF/?uri=CELEX:32014R1297
&from=EN
ENFORCING PACKAGING REQUIREMENTS
ECHA's Forum of Enforcement Authorities is kicking off a project focusing on the safe packaging of consumer products requiring child-resistant
fastening. Typical examples of such products with child-resistant fastenings are grill lighter fluids, disinfectants, cleaning and laundry products
as well as drain unblockers.
Inspectors in 15 Member States will target companies – from manufacturers 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.
clp
10
RAPEX – keeping European consumers safe from
chemical risks
TEXT BY VIRGINIA MERCOURI
The variety of products traded across national borders is growing
every day. To make sure that consumers are safe, national authorities 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 communicated 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 product (other than a pharmaceutical or
medical device) is withdrawn from
the market or recalled, the European 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, removed from the market or recalled
from consumers who have already
bought them.
CHEMICAL RISKS IN CONSUMER
PRODUCTS
Around one quarter of all notifications sent through RAPEX have
been about the presence of chemicals 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
© EUROPEAN COMMISSION
• 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.
RAPEX stands for the EU’s Rapid Exchange
System for information on dangerous nonfood products.
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 because they contained carcinogenic
azodyes or phthalates.
rapid alert system, more than 1 200
notifications involving the
unauthorised presence of DEHP
have been made, the overwhelming
majority related to toys.
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 example is a doll imported from China
which contained the plasticiser
DEHP in a concentration of 38.5 %
by weight. Since the launch of the
people and perspectives
To enhance the effectiveness of
controls, there is now stronger collaboration between market surveillance authorities and customs
authorities. Relevant information
from RAPEX is regularly transferred to the EU wide customs risk
management system, which uses
common risk selection criteria for
controls and the computerised
exchange of information on movement 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 dimethylfumarate (DMFu) to keep the leather dry.
This caused serious skin burns and
injuries, leading to costly product
recalls and an EU-wide emergency
ban.
11
© EUROPEAN COMMISSION
In 2014, one in every four RAPEX alerts was about serious chemical risks in consumer products.
The recurrent RAPEX notifications about products containing
DMFu contributed to a permanent
restriction under REACH of articles
containing DMFu in concentrations greater than 0.1%. Since the
restriction came into force in 2012,
the number of RAPEX notifications
on DMFu has gone down significantly.
BUSINESS RESPONSIBILITIES
The General Product Safety Directive, 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 market; 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/addressingchemicals-of-concern/restrictions/list-ofrestrictions
REACH restrictions under
consideration
http://echa.europa.eu/restrictions-underconsideration
Forum for exchange of information
on enforcement
http://echa.europa.eu/about-us/who-weare/enforcement-forum
The joint action on chemicals in
clothing
http://www.prosafe.org/index.
php?option=com_content&view=article&i
d=129:chemicals-in-clothing&catid=53:20
13&Itemid=607
MAKING SEARCHES IN RAPEX
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
people and perspectives
HOW IS RAPEX USED?
“RAPEX is an important tool for
consumer organisations. It is widely
used to monitor the level of product safety in the EU and to encourage more product testing. However,
RAPEX has an untapped potential.
We want to see it further strengthened as an effective enforcement
tool”.
Sylvia Maurer, Head of Sustainability and Safety at the European
Consumer Organisation BEUC
*******
“The fourth joint REACH Enforcement 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. Furthermore, the number of RAPEX notifications 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
12
Skin sensitisation – new methods to replace
animal testing
INTERVIEW BY TIIU BRÄUTIGAM
All substances registered under
REACH need to contain information on their skin sensitisation 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 computerbased 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 European 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 validating new alternative test methods in
recent years.
“A recent example of REACH
encouraging the use of alternative
test methods is related to skin corrosion/irritation and to serious eye
damage/eye irritation. 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,” she points out.
© FOTOLIA
Registrants should get familiar with the advice on how to use alternative methods instead of
testing on animals.
ALTERNATIVE METHODS TO BE
USED IN COMBINATION
Ms Casati highlights that we now
have a variety of alternative methods, addressing the biological and
chemical mechanisms of skin sensitisation. However, none of these
methods can currently be used in
isolation.
“They don’t predict the final effect,
but provide information on specific mechanisms, underlining the
adverse effect. The challenge is to
understand how to use these alternative 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
reach
is already available for REACH registrants. Additionally, we at EURLECVAM 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 upcoming 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 alternative method progresses from a
proposal for validation through to
its final adoption into the regulatory 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 international validation centres. Its public
release is planned for autumn 2015.
13
© ECHA
a rational way. “With the existing
methods available, it is now up
to the registrant to build a wellthought case, based on the guidance 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.
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.
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 alternative 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.
In vivo: Test conducted on a living
organism.
In chemico: The use of abiotic (nonanimal or in vitro) measurements
of the reactivity or other physicochemical properties of compounds.
In silico: Test which is done or produced 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-crosssector-workshop-on-alternatives-forskin-sensitization-testing-and-assessment/
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/factsheets
Terminology – in 23 languages
http://echa-term.echa.europa.eu/
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 identification, we are almost there,” she
highlights.
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, describing the main biological steps. They are relevant for many registrants preparing for the 2018 REACH registration deadline and, if used correctly,
can replace the need to use animal test methods.
Ms Casati is also confident that new
methods, currently under development, might overcome some of the
existing limitations in the near future. The information that the new
alternative methods provide needs
to be used well and interpreted in
The draft OECD test guideline is:
• In Vitro human cell line activation test (h-CLAT).
NEW OECD TEST GUIDELINES AVAILABLE
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).
http://echa.europa.eu/support/oecd-eu-test-guidelines
reach
14
Notifying the trade of hazardous chemicals more
easily through ePIC
INTERVIEW BY PAUL TROUTH
In the first quarter of each year,
exporters and importers of hazardous 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 company, Novafito S.p.A., to ask how
they have adapted to ePIC.
Novafito S.p.A.’s main activities
relate to the export and distribution 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 import authorisation from the importing 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 using 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
© MARCO PIRINOLI
© ALBERTA SBARUFATTI
Having the whole reporting process now in ePIC makes it more efficient and less errorprone. From the left: Marco Pirinoli and Alberta Sbarufatti.
more resources and staff that can
be dedicated to the PIC work. However, they are also likely to have
more products affected by PIC than
we do,” he says. “Of course, while
the multinationals can hire employees 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 notifications by ourselves and so we
needed to learn how the ePIC system worked,” says Ms Sbarufatti.
Aside from their own notifications,
Novafito S.p.A. has also submitted
export notifications on behalf of
another Italian company, Finchimica. 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
pic
able to quickly learn to use it to submit 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 offered 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, waiting for a response from the national
authorities can take time and this
is something we think needs to improve,” 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 retrieve these details without having
to input them manually.
NOTIFYING ELECTRONICALLY
Novafito S.p.A. sees the new system
of reporting electronically as a positive development. The previous tool,
EDEXIM, did not allow this reporting obligation which was therefore
managed outside the system.
15
“Moving the reporting to an electronic 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 notifications that were submitted last
year. We only need to check them
and send them to the authorities using ePIC,” Ms Sbarufatti confirms.
Since companies report to the authorities 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.
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, Brazil, 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. 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 asking 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 Regulation
http://echa.europa.eu/regulations/priorinformed-consent-regulation
Export notification procedure
http://echa.europa.eu/regulations/priorinformed-consent/export-notificationprocedure
Annual reporting on PIC chemicals
http://echa.europa.eu/regulations/priorinformed-consent/annual-reporting-onpic-exports-and-imports
Guidance on PIC
http://echa.europa.eu/regulations/priorinformed-consent/understanding-pic
ePIC
http://echa.europa.eu/support/dossiersubmission-tools/epic
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.
pic
16
How ECHA assesses your read-across
TEXT BY TIIU BRÄUTIGAM
Read-across is the most commonly used alternative to testing chemicals on animals under
REACH. The Read-Across Assessment Framework (RAAF)
shows how ECHA assesses
read-across in registration dossiers.
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 scientific evaluation of read-across
justifications in registration dossiers. The first part covers readacross 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 consistently during dossier evaluation.
The RAAF does not replace the
official guidance on read-across for
registrants but complements it by
showing how ECHA assesses readacross 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 readacross 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
© FOTOLIA
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.
experts to improve their explanations of why and how read-across
can be used in dossiers.
CONSISTENCY
The RAAF structures the scientific 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 documentation, scientific reasoning or
supporting evidence. The outcome
of ECHA’s assessment will be a conclusion on whether the read-across
is scientifically acceptable or not.
ECHA is planning an update to the
RAAF next year to cover environmental endpoints.
ASSESSMENT THROUGH
SCENARIOS
Read-across approaches are assessed using six different scenarios and their respective assessment
reach
elements and assessment options.
The scenarios describe different
grouping and read-across approaches.
Each scenario has several assessment elements which are crucial
when judging how valid and reliable
a read-across is. The assessment
elements contain detailed explanations and examples. For each
assessment element, an assessor is
guided through a series of questions to select the most appropriate assessment option.
Further information:
Grouping of substances and
read-across
http://echa.europa.eu/support/groupingof-substances-and-read-across
Information toolkit
http://echa.europa.eu/support/information-toolkit
Factsheet – Role of Animal Testing
in ensuring the Safe use of
Chemical Substances
http://echa.europa.eu/publications/factsheets
Terminology – in 23 languages
http://echa-term.echa.europa.eu/