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SHISHER KUMRAEXECUTIVE DIRECTOR
SSS (EUROPE) AB(REACH Only Representative)
http://www.sustainability-support.com/
REACH Compliance Management
- Substance in Article
Has there been an increase in queries from the European buyers regarding the export articles being certified for the
presence or absence of SVHC?
Would you like to avail business benefits from REACH compliance in terms of market
expansion?
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?
Would your company like to know about alternative methods (strongly recommended by the REACH regulators) to comply with
your obligations within REACH?
Do you need support from Industry association or other export promotion agency to facilitate you to be
able to comply with the REACH Requirements?
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 assurancesBuyer would prefer assurances from an EU
based entityWill 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 articleSecure information from the supply chain where its
not readily availableAssess 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 farSVHC list will be updated each year 3 – 4
timesBy 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 life-cycle 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. 1-10 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 / intentionalNature of the substance – Toxic or notTonnage 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 4-Aminodiphenyl in Grey-Black main
5,02 ppm of o-Toluidine, 6,14 ppm of 4-Aminobiphenyl, 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 marketImport rejected by customs authorities Sales ban ordered by the authoritiesWithdrawal and recall from consumers
ordered by the authoritiesFinancial 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/