1. REACH Compliance Management - Substance in Article
Shisher Kumra
Executive Director
SSS (Europe) AB
(REACH Only Representative)

2. Has there been an increase in queries from the European buyers regarding the export articles being certified for the presence or absence of SVHC?

3. Would you like to avail business benefits from REACH compliance in terms of market expansion?

4. 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?

5. Would your company like to know about alternative methods (strongly recommended by the REACH regulators) to comply with your obligations within REACH?

6. Do you need support from Industry association or other export promotion agency to facilitate you to be able to comply with the REACH Requirements?

7. 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

8. 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

9. 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

10. 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.

11. 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 for these lists

12. 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

13. 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

14. 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

15. 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.

16. 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. “

17. 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

18. 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.

19. 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

20. 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 tones, tones, tones or ≥1000 tones (this information can be determined as explained in section 0)
And the eSDS as described in previous slide

21. 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

22. Enforcement - Penalties
If it was deliberate / intentional
Nature of the substance – Toxic or not
Tonnage band for which – infringement was done

23. Articles: REACH Non-Compliance

24. 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.

25. 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

26. 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

27. Thank you Contact Details: Shisher Kumra
Executive Director, SSS (Europe) AB
Ph: