Certificate of compliance with regulations Reach for

REGLEMENTATIONS REACH REACH Declaration

Pakflex/4/1 Sep 2011
Pakflex Series (water based flexographic ink)
Substance and Company Identification


Product
Manufacturer
: Flexographic Water Based Printing Ink
: Flint Ink and Chemical Industry Private Limited
53-55 Pandan Loop, JTC Industrial Estate
Singapore 128270
Tel: +65-67782388
Fax: +65-67782797
Email: [email protected], [email protected]
Declaration
We hereby declare that that we have not intentionally used the 53 substances listed in
the attached sheet of the SVHC (Substances of Very High Concern) Candidate List
by REACH as of 1 Sep 2011, as raw materials and in the manufacturing process of
the above product supplied. The Candidate List published by ECHA (European
Chemical Agency) is regularly updated when new substances have been identified as
SVHC.
On the REACH Regulation, registration of substances in the articles is obligatory for
an article producer if the following conditions are met;
 The substances are intended to be released from the produced articles during
normal foreseeable conditions of use.
 The total amount of substances present in the articles with intended releases
produced exceed 1 ton per year per producer
 The substance which is included in the SVHC Candidate List is present in all
articles produced in an amount totaling over 1 ton per year per producer and is
present in articles above a concentration of 0.1% weight by weight (w/w)
 Producer is obliged to register or notify substance presence when the series of
above conditions are met.
 If one of the conditions are not met, ie Article (57): substance is not
intentionally released during use, then Article (59(I)) states that knowledge of
the exact tonnage is not necessary as the obligation to register or notify does
not apply.
1
2
Other Information

Flint Ink and Chemical Industry Pte Ltd makes no warranty, representation or
guarantee regarding the suitability of this information or other data provided by
Flint Ink and Chemical Industry Pte Ltd on environmentally hazardous
substances, nor does Flint Ink and Chemical Industry Pte Ltd assume any
liability arising from the use of this information and specifically disclaims any
and all consequential and incidental damages. This information herein is given
in good faith. It is confidential and submitted solely for your organization’s
internal use
3
H. B. Fuller Deutschland GmbH
An der Roten Bleiche 2-3, 21335 Lüneburg
Postfach 20 50, 21310 Lüneburg
Tél. +49 4131 705 - 0
Fax +49 4131 705 - 227
Société NEW PACK
Route Digue – BP 1484
MG - ANTANANARIVO
Lunebourg, 27.09.2012
La réglementation REACH
Chère Mme Rameliarison,
La réglementation européenne REACH (1907/2006/CE) est entrée en vigueur le 1er juin 2007. Sa
mise en œuvre est prévue selon une approche progressive. La prochaine échéance
d'enregistrement REACH, fixée au 1er juin 2013, approchant à grands pas, nous aimerions faire
le point pour vous sur la situation actuelle concernant les droits d'enregistrement, la
communication des numéros d'enregistrement et les substances extrêmement préoccupantes
(SVHC).
Les fabricants ou importateurs de substances CMR au-delà de 1 tonne/an, de substances
classées comme écotoxiques (R50/53) au-delà de 100 tonnes/an ou d'autres substances au-delà
de 1000 tonnes/an sont tenus d'avoir enregistré leurs produits avant le 1er décembre 2010. Les
fabricants et importateurs de substances au-delà de 100 tonnes/an doivent soumettre un dossier
d'enregistrement à l'Agence européenne des produits chimiques (AEPC) au plus tard le 1er juin
2013. Il est important de noter qu'H. B. Fuller est considéré comme un utilisateur en aval (UA)
dans le cadre de la réglementation REACH, et nous comptons sur nos fournisseurs en amont,
fabricants ou importateurs, qui devront avoir organisé l'enregistrement de leurs produits. Afin de
nous en assurer, nous avons contacté tous nos fournisseurs pour obtenir des déclarations de
conformité pour toutes les matières premières qui sont utilisées dans nos produits formulés qui
vous sont fournis.
Les numéros d'immatriculation seront communiqués par la chaîne d'approvisionnement via les
fiches de données de sécurité (FDS). Aucune communication supplémentaire de numéros
d'enregistrement n'est nécessaire. Dans la mesure où ces changements ne sont pas considérés
comme des changements majeurs (voir art. 31 (9) de la réglementation REACH) dans la FDS, ils
ne déclenchent pas de mise à jour des FDS à envoyer aux clients. Par conséquent, on ne
s'attend pas à ce que l'indication des enregistrements effectués soit rapidement communiquée
aux utilisateurs en aval après la date limite d'enregistrement. En outre, il est clair que nombre de
substances bénéficieront de la période de transition jusqu'en 2018, selon l'article 23 de la
réglementation REACH. Il est prévu que les numéros d'enregistrement de ces substances ne
seront pas disponibles avant la date limite correspondante.
La teneur en SVHC des mélanges doit être indiquée dans la section 3 des feuilles de données de
sécurité, comme requis par l'annexe II de la réglementation REACH. Veuillez vous référer à nos
FDS pour toutes informations sur les SVHC.
H. B. Fuller Deutschland GmbH, D-21335 Lüneburg, An der Roten Bleiche 2-3
Geschäftsführer: James McCreary, Ralf Jörg Müller
Sitz: Lüneburg, Handelsregister: Amtsgericht Lüneburg, HRB 2337; UST-ID-Nr. DE 813 310 592; Steuer-Nr. 33/203/00883
Bank of America N.A., Frankfurt (BLZ 500 109 00) Konto 19209012, IBAN DE08 5001 0900 0019 2090 12, SWIFT code BOFADEFX
La liste des SVHC continuera de croître au fil du temps et, par conséquent, H. B. Fuller a engagé
un projet actif d'identification immédiate de toutes les substances SVHC candidates présentes
dans nos formulations. Si un problème venait à se présenter, nous avons pour politique de
reformuler et de remplacer dans la mesure du possible ces matériaux par des ingrédients
présentant un profil de risque réduit. Cette ligne de conduite sera communiquée à nos clients
d'une manière convenue le cas échéant.
Vous pouvez rester assurés qu'H. B. Fuller suivra les activités d'enregistrement de ses
fournisseurs et que nous continuerons à fournir des produits de qualité dans le respect de tous
les aspects de la réglementation REACH.
Je vous prie d'agréer l'expression de ma considération distinguée.
Ce document a été préparé sous forme électronique et est valable sans signature
P.J. Fiches de donnée de sécurité de la Fullrez EC 9530.
ICAT
S.r.l.
Via dell’Arbetraccio, 6
I - 06022 FOSSATO DI VICO (PG)
Tel +39 075 914971 – Fax +39 075 9190125
E-mail: [email protected] – Web: www.icat.it
P.IVA 01544190547 – Cod.iso IT 01544190547
Mess.rs
NEWPACK
Route Digue-BP 1484
ANTANANARIVO - MADAGASCAR
Fossato di Vico, 01/10/2012
Esteemed Sirs,
Referring to your inquiry, regarding restrictions for the use of dangerous substances, all the
adhesives included in the following categories:
ICAMELT
WORLDMELT
ICAVIL
ICAGEL
- hotmelt adhesives in granules and in pillows,
- new generations hotmelt adhesives ,
- synthetic adhesives in water dispersion,
- proteich adhesives in powder and paste,
do not contain dangerous substances for human health and they are not containing substances
listed in SVHC list published by ECHA in date 18/06/2012, as described in MSDS.
As we are not producer of chemical substances,
substances, but raw materials blenders, our adhesives are
nt subjected to preregistration / registration. Anyway we are cooperating with all our raw
materials suppliers so that all subtances subjected to it will be properly registered .
For every further info you can contact our reach responsibles at the following email address:
[email protected] .
Best Regards,
ICAT Srl
Sun Chemical A/S
Reach Information Center
Københavnsvej 112
DK-4600 Køge
Denmark
T +45 56 67 75 85
F +45 56 67 75 86
www.sunchemical.com
To whom it may concern
September 2012
REACH Registration and Pre-registration
Sun Chemical has successfully registered all substances with 2010 deadline. We will inform you registration numbers as part of updated Safety Data Sheets. None of the registrations require exposure scenario as they are either non-hazardous or monomers in imported polymers. It is our intention to register
all substances for which we are liable with the timelines 2013 and 2018 as given by REACH.
Sun Chemical does not provide specific information on product composition or when we will register individual ingredients or from where we will source the products. This is regarded as confidential business
information.
We can inform that for all substances with registration deadline 2013, we are currently working as colead company for consortia or monitoring closely consortia working on joint registration dossier. All consortia are expecting to meet the deadlines for joint submission registration.
This letter also confirms Sun Chemical Performance Pigments and Sun Chemical Inks have successfully
pre-registered all substances for which we are liable as importer or manufacturer to pre-register.
Customers purchasing from Sun Chemical outside EU will not be covered by the pre-registration or registrations.
We have also received confirmation from all non-EEA suppliers setting up only representatives in EEA
that Sun Chemical import will be covered by intended registration. Sun Chemical will inform you on registration when registration numbers are available. This will be part of an updated Safety Data Sheet.
Sun Chemical will not use the pre-registration number for confirmation as this number is not mandatory
information in the supply chain and therefore does not exist for all substances we have available.
In case suppliers will not register we will inform you as soon as we have the information and advice on
alternatives to ensure our customers’ success. We have identified alternative suppliers for the majority of
our raw materials.
Sun Chemical products are mainly mixtures of substances. A REACH-compliant product will therefore
be dependant on the requirements for the individual substances in the product. This will include per substance: time-line for registration, hazard profile and restrictions/authorization if any.
We will ensure compliance and include registration numbers in our SDS following registration. We will
also provide exposure scenarios including exposure estimates where required (substances above 10 ton
per year). The SDS may change for some of our products over the next few years, but the product will
be REACH compliant at any given point in time.
Sun Chemical A/S
Reach Information Center
Københavnsvej 112
DK-4600 Køge
Denmark
T +45 56 67 75 85
F +45 56 67 75 86
www.sunchemical.com
Information on substances of very high concern
rd
This information is valid for the 54 substances in consultation on September 3 , 2012, the candidate list
found on ECHA’s homepage including 84 substances as updated on 18 June 2012, as well as Annex
XIV 1st, 2nd, 3rd and 4th recommendations.
Sun Chemical’s products intended for the EU market do not contain any known amounts of substances
of very high concern (SVHCs) at more than 0.1% (or the lowest concentration limit specified in Part 3 of
Annex VI to Regulation (EC) No 1272/2008 which results in the classification as a SVHC), which could
be subject to potential future authorization process (as outlined in REACH Art 56).
For customers outside of the EU, please request our current EU label and SDS when considering exports to the EU based upon our non-EU products.
The Sun Chemical stewardship program does not accept listed candidate SVHC’s as part of new products and we are looking to substitute those in our existing non-EU product portfolio. Information on substance use restrictions will continue to be communicated as part of our SDS.
Articles are specifically excluded from consideration under REACH, however there are specific circumstances related to articles where this does not apply. In these cases, we recommend that you contact
your REACH specialist.
In case any further information is required we kindly ask you to contact your Sun Chemical sales representative.
Substance Evaluation
Substance evaluation is the process under REACH that allows for risk clarification of substances which
are suspected of posing risk to human health or the environment. ECHA has recently published the first
draft of substances for evaluation under the program known as “Community Rolling Action Plan”
(CoRAP) through 2015. The draft plan contains substances for which there is a suspicion that their use
could pose a risk to human health or the environment. In general, the uses of these substances cover
various areas and are not focusing on any particular industrial, professional or consumer uses. Following the evaluation further information may be requested from the registrants of the substances if additional data is considered necessary to clarify the suspected risk. Alternatively, it may be concluded that
the substance does not constitute a risk and no further data is needed.
Hence, Sun Chemical regards the evaluation as a tool to clarify the risk and may in future clarify the
need for further exposure control, restriction in use or listing as SVHC based on sound science. Sun
Chemical does use some of the substances listed on CoRAP, but is not a registrant of any of the substances. We will as soon as we have further information provide more information, mainly as part of the
SDS. Chemical substances on the CoRAP list have not in all cases been determined to be hazardous to
human health and the environment in the Eu under the guidelines of CLP; for those that have they are
currently disclosed in Section 3 of our SDS for each product .
Sun Chemical A/S
Reach Information Center
Københavnsvej 112
DK-4600 Køge
Denmark
T +45 56 67 75 85
F +45 56 67 75 86
www.sunchemical.com
CLP-regulation
Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP
Regulation) require any manufacturer or importer to:
1)
notify European Chemical Agency (ECHA) on classification for all hazardous substances and all nonclassified substances imported or manufactured above 1 tpa.
2)
First notification must be done for all substances on the market 1 December 2010 before January 3rd
, 2011
3) Any other substance placed on the market must be notified within 1 month after placing on the
market.
Sun Chemcial has notified to ECHA all substances on the market 1 December 2010 identified by CAS nos,
that Sun Chemical manufacture within Europe or import into an European Sun Chemical legal entity.
We have also an internal procedure to make sure new substances for which we are liable to notify ECHA will
be notified within 1 month after their placing on the market.
For customers where an agreement is in place, Sun Chemical has also notified ECHA on classification, this
apply e.g. to customers receiving products from Sun Chemical Switzerland or Sun Chemical Turkey.
For customers, where we have no agreement in place, Sun Chemical has not notified ECHA.
Exposure Scenarios, Identified uses and Use Descriptor System
It is the right of any Sun Chemical customer to inform us on known uses to make it an identified use and
become included in chemical safety assessment including preparation of exposure scenarios.
Sun Chemical will as reliable supplier consider any identified use made known to us where the REACHlegislation require us to, and where Sun Chemical is not the registrant we shall pass on the information
to our suppliers.
However, we need customers to accept that it is not necessary in the following cases according to
REACH article 14 and 37.4:
- The EU SDS supplied by Sun Chemical informs the product is not classified, does not contain
information on a dangerous substance >1% (w/w) or does not contain information on candidate
substances, PBTs or vPvBs >0.1%(w/w).
- The purchase of a Sun Chemical product is less than 1 tonne per year
- If a Chemical Safety Report is not required to be completed
- If the substance volume registered by the registrant entity is less than 10 tonne per year
We already supply information on appropriate risk management recommendation in the SDS for preparations and substances in above instances.
Sun Chemical will request suppliers to include or pass up the supply chain the following uses for inks
related materials:
Manufacture
Application
Product
Category
PC 18
PC 18
Sector
of Use
SU 10
SU 3
Process Category
PROC 1, 2, 3, 5, 8a, 8b, 9
PROC 2, 3, 4, 5, 8b, 10
Article
Category
N/A
N/A
Environmental Release Category
ERC 2
ERC 4, 5
Ref: ECHA Guidance on information requirements and chemical safety assessment, version 1.2; May 2008
Sun Chemical A/S
Reach Information Center
Københavnsvej 112
DK-4600 Køge
Denmark
T +45 56 67 75 85
F +45 56 67 75 86
www.sunchemical.com
Sun Chemical will implement generic exposure scenarios developed by CEPE as soon as possible. We
are currently not in a position to distribute for inks and inks related materials, but we will forward all ES
received by suppliers to ensure compliance.
Pigments and pigment preparations are generally speaking not classified and the Chemical Safety Report is not required to be completed and exposure scenarios will not be developed. For the registration
dossier we will include PC, SU, PROC, AC and ERC as required for registration and the continued use
by Sun Chemical customers, including personal care products.
For pigments and pigment preparations classified as dangerous and purchased above 1 tonne per year
we recommend contacting us for inclusion of your specific use.
Sincerely Yours
Ivan Grønning
Manager, Regulatory Affairs Europe, REACH Operations
Contact: [email protected]