Transcript REACH Compliance Management

REACH Compliance Management
- Substance in Article
SHISHER KUMRA
EXECUTIVE DIRECTOR
SSS (EUROPE) AB
(REACH Only Representative)
http://www.sustainability-support.com/
Has there been an increase in queries from the European buyers regarding
the export articles being certified for the presence or absence of SVHC?
No
36%
Yes
64%
Would you like to avail business benefits from
REACH compliance in terms of market expansion?
No
0%
Yes
100%
Do you think that testing is a feasible option to provide the certificate
requested by your buyers given that there shall be regular updates to the
SVHC list?
Yes
45%
No
55%
Would your company like to know about alternative methods (strongly
recommended by the REACH regulators) to comply with your obligations
within REACH?
No
0%
Yes
100%
Do you need support from Industry association or other export
promotion agency to facilitate you to be able to comply with the
REACH Requirements?
No
9%
Yes
91%
Need for REACH Compliance for Japanese
Exporters to EU
 Buyers in EU requires independent assurances and
declarations on
Free of Restricted substances
 SVHC Free (or below 0.1% wt./wt.)
 REACH Compliance

 Buyer prefer 3rd part assurances
 Buyer would prefer assurances from an EU based
entity
 Will Require Declaration irrespective of the
possibility / probability of SVHC presence
Essentials of Declaration of Compliance
 What is being declared? Is this relevant from




buyers compliance check point of view?
Does it clearly relate to the supplier and the
products supplied?
Who is making the declaration, - signing authority
for the supplying company?
Is there reason for concern over the validity of the
declaration? If yes, access to any documentation
supporting the declaration should be requested.
Validity of declaration – time and SVHC list
Benefits of timely compliance
• Compliant image of the company
• EU buyer would continue to buy
• Increase in EU exports – at the cost on non-
compliant suppliers
• Similar law is expected in other countries – better
prepared for such eventualities
• Plan the substitution of SVHC chemical
• Safer product for Human health and environment
Key issues – Relating to Quantifying Substance in
Articles
 The 1 ton criteria is applicable to a Indian exporter
for all its products (exported to EU) that have a
particular SVHC > 0.1%


Its not as per the product type / variety / category
Its is summation of all products with SVHC > 0.1%
 From EU buyer point of view its summation of all
purchases (from EU or non-EU supplies) of all
products that have a particular SVHC > 0.1% wt./wt.
Proactive Preparation for Compliance
 Review the Chemicals used in the article
 Secure information from the supply chain where its not
readily available
 Assess the unofficial Lists of ”chemicals of concerns” (only
from preparedness point of view)






hazardous substances contained in Tables 3.1 and 3.2 of Annex VI of the
CLP Regulation (EC) No 1272/2008
Monographs Database of the International Agency for Research on
Cancer (IARC)
PBT info. System within European Substance Info. System (ESIS)
SIN List of International Chemical secretariat
Priority List of European Trade Union Confederation
Visit www.reach-support.com for these lists
Challenges to comply with REACH – Sub. In
Articles Regulation
 SVHC list is only partially ready – 53 so far
 SVHC list will be updated each year 3 – 4 times
 By end of 2012 SVHC list is expected to contain
about 136 substances
Difficulty with chemical Analysis
 SVHC analysis (in Labs) for each chemical would be
very challenging and expensive;
 Several labs may not have capacity to analysis each
of these SVHCs
 Further the list will be updated so often and will
need to follow up analysis again and again – its
impractical & expensive
 Non-analytical approaches may therefore be more
useful
Difficulties of chemical analyses
 Articles may be very complex and composed of
different parts and materials. It is therefore
difficult to create a representative sample
 Substances that are included in the article matrix
may have to be extracted from it.
This may result in chemical reactions that could “create”
substances which do not exist in the article.
 The extraction may not be exhaustive, thus the full
content of substances in the matrix may not be obtainable

Difficulties in Chemical Analysis:
 Some methods may show the existence of certain
elements (e.g. halogens) rather than the existence
of substances.
 If a high number of different substances are
contained, several analyses may be needed to
identify all substances, and it is particularly
difficult to assign an appropriate method if it is not
clear what is being searched.
 The quantification of substances requires
additional measurements.
ECHA – Recommends the following
 ” Although chemical analyses may be helpful in
certain situations, it is to be noted that they may
yield ambiguous results and/or be very costly and
are thus not recommended as the preferred
instrument for obtaining information. “
Supply Chain Communication
 It may be helpful to tell suppliers why the information is needed,
 In most cases exact composition of articles is not needed to clarify
whether requirements for substances in articles have to be fulfilled.
 No obligations for substances in articles apply can also be achieved by
excluding or limiting the presence of substances that are on the
candidate list of substances for authorization.
 Suppliers could for example provide 3rd party Certificate backed by
analysis and relevant documentation which guarantee that certain
substances are not used in the manufacture of their products or remain
below certain concentrations in their products.
 A different approach would be to include respective criteria in supply
contracts excluding or limiting the presence of certain substances in the
products to be supplied
Supply Chain Communication
 It is recommended that requests in the supply chain
are targeted and aim at excluding or limiting the
presence of certain substances (e.g. those on the
candidate list for authorization) instead of asking for
the exact composition of articles or mixtures, which
is more often confidential information.
Compliance Requirements
 When SVHC is > 0.1% and < 1 TPA (eSDS –
according REACH & CLP Regulation)







Appoint an Only Representative
what the downstream life-cycle stages of the article are up to final
disposal (transport, storage, uses)
what the potential routes of exposure are during each of these lifecycle stages
what the hazards of the SVHC are for human health and the
environment
what types of exposure control / personal protection measures are
likely to be appropriate during each of the life-cycle stages in order
for the handling of the article to be considered safe
instructions for use and packaging , information on labels
link to a website with up-to-date information
Compliance Requirements
 Notification when SVHC > 0.1% & > 1 tpa








Appoint an Only Representative
the identity and contact details of the producer or importer of the
articles
the registration number for the substance, if available
the identity of the SVHC (this information is available from the
candidate list and the supporting documentation)
the classification of the substance
a brief description of the use(s) of the substance in the article(s) as
specified in section 3.5 of Annex VI and of the uses of the article(s)
the tonnage range of the substance contained in the articles, i.e. 110 tones, 10-100 tones, 100-1000 tones or ≥1000 tones (this
information can be determined as explained in section 0)
And the eSDS as described in previous slide
Compliance Requirements
 Substance with intentional release > 1 TPA
 Appoint an Only Representative
 Later Pre-Registration (if applicable)
 Register the substance according to Tonnage and deadline
Enforcement - Penalties
 If it was deliberate / intentional
 Nature of the substance – Toxic or not
 Tonnage band for which – infringement was done
Articles: REACH Non-Compliance
Reasons: Chemicals contained
 1 183 – 3730 ppm of benzidine
 8,7 mg/kg of 3,3’-Dimethoxybenzidine, 1248,7
mg/kg of Benzidine and 36,6 mg/kg of 4Aminodiphenyl in Grey-Black main
 5,02 ppm of o-Toluidine, 6,14 ppm of 4Aminobiphenyl, 219,21 ppm of Benzidine, 5,16 ppm
of 3,3’-Dimethylbenzidine, 11,47 ppm of 3,3’Dimethoxybenzidine in the red strap around neck.
Enforcement: Action Taken
 Voluntary corrective action.
 Voluntary withdrawal from the market
 Import rejected by customs authorities
 Sales ban ordered by the authorities
 Withdrawal and recall from consumers ordered by
the authorities
 Financial penalties
In Summary: REACH Compliance Management
• Use cost effective non-analytical approaches for
ascertaining presence of SVHC
• Articles with Intentional release To follow
•
•
Pre-Registration , SIEF, data sharing, data ownership,
Registration, Export declaration, SDS, etc.
• Substance in Article with > 0.1% SVHC
– Info in supply chain – SDS & eSDS
• Substance in Articles with > 0.1% SVHC ; > 1 tpa
– Info in supply chain – SDS / eSDS
– Notification to ECHA
 Thank you
 Contact Details:
 Shisher Kumra
 Executive Director, SSS (Europe) AB
 Ph: 0046733650399
 [email protected]
 http://www.sustainability-support.com/