REACH, Substances of Very High Concern (SVHC) & Articles: Dr. Rashmi Naidu

REACH, substances of very high concern
(SVHC) & Articles
Dr. Rashmi Naidu

Sr. General Manager (Technical Services)
REACH Support, INDIA
http://www.reach-support.com
About REACH Support
Most sought after, one of its kind helpdesk in Asia
Clientele spread across Asia, Europe and growing rapidly to other continents
Caters to over 800 to 900 companies presently
Entire basket of REACH compliance services offered
Professionals comprise of experts who have been following REACH regulation

since the draft stages
Offers compliance assistance services for other European regulations like

Classification Labelling and Packaging (CLP), Biocidal Products Directive
(BPD), Eco-design requirements for energy using products (ErP), Turkish
Inventory of chemicals and Chemical substances control law of Japan, etc
Contents
REACH in a nutshell
What are SVHC?
SVHC & Restricted Substances (Annex XVII of the REACH regulation)
What is an Article
REACH requirement for substances in article
When is a release intentional
Notification of SVHC & Notification deadlines
Undertaking/Certificates requested by the European buyers

REACH – In a nutshell
o Pre-registration & Registration of chemicals by non-EU manufacturers

through an “only representative” (OR)
o Notification or Communication of Substances of Very High Concern
(SVHC) in articles
o Evaluation (of some chemicals) by the competent authorities in Member
States
o Authorization (of certain SVHC) by ECHA for specific use/ application
(applicable only to EU article manufacturers)
o Restriction on placing of CHemical substances in the EU market
Substances of very high concern (SVHC)
What are SVHC
Substances of very high concern are:
• PBT substances
• vPvB substances
• CMR category 1, 2 substances
Substances of equivalent concern (having endocrine

disrupting properties)
In a nutshell, extremely toxic substances shall be categorized

as SVHC
SVHC & Restricted Substances (Annex XVII) of REACH
The list of 46 finalized SVHC can be found at

http://reach-or.com/reach_or_pdf/SVHC%2015.12.10.pdf
SVHC list shall be updated at least 2 times every year
Annex XVII (52 substances & in some cases category of
substances (Phthalates, PAHs, CMR substances in Annex I of
EC/67/548)
Restrictions on the Manufacture, Placing on the Market and

Use of Certain Dangerous Substances, Preparations and
Articles
Name & category of chemicals
Conditions of Restriction
What is an article
Definition of an “Article” as given in REACH regulation
An object which during production is given a special

shape, surface or design which determines its function
to a greater degree than its chemical composition
(REACH Article 3(3))
An article is composed of one or more substances or
preparations.
Specific substances may be added to give the article special
properties
Examples furniture, clothes, vehicles, computer, toys etc.

Borderline cases
Paint Spray Fire Car Thermo-

in pot can cracker battery meter
Substance
Preparation Article
REACH Requirements for Substances in Article
Obligation Conditions Type of chemicals
Registration Intentional release > All chemicals

1 TPA
Notification > 0.1% w/w and > 1 SVHC

TPA
Communication < 0.1 % w/w and < 1 SVHC

TPA
What is an intentional release
Release which is deliberate under normal or foreseeable conditions of
use and adds value to the function of an article
If there is an intentional release, exporters should calculate

If Substance (which is released) is present in greater than one ton in the
export consignment (per annum)
If yes, then the intentional release substance has to be pre-registered and
later registered
Registration deadline shall normally be decided by the tonnage of the
intentional release substance
Intentional release should not be confused with accidental release

Examples – Mercury coming out of the thermometer when thermometer
breaks
Acid coming out of faulty batteries, etc
Notification Requirements to the ECHA
The information to be notified includes the following:
• The identity and contact details of the producer

• The registration number (s) for the substance, if available
• The identity of the substance (s) like name of the substance,
CAS, EINECS No, etc
• The classification of the substance, which will be available
from the Agency
• A brief description of the use (s) of the substance in the article
and of the uses of the article (s)
• The tonnage range of the substance, i.e. 1-10 tonnes, 10-100
tonnes etc.
Notification Deadlines
For substances included in the SVHC list before 1 December

2010, the notifications have to be submitted not later than 1
June 2011
For substances included in the SVHC list on or after 1

December 2010, the notifications have to be submitted no
later than 6 months after the inclusion
Notification has to be done through the only representative
who has to be a European legal entity
Communication Requirements to the ECHA
Communicate to the recipient of the article with sufficient

information to allow safe use of the article including,
as a minimum, the name of the substance”

Only for SVHC on the ‘Candidate List’
No tonnage limit (i.e. also applies below 1 tonne/year)

This communication can also be provided through the safety data
sheet (SDS)
Article 33(2):
Consumers can request the same information. The information
should be provided within 45 days, free of charge.
Sample undertakings/certificates (SVHC)
Undertaking in case SVHC is greater than 0.1%wt/wt
I hereby declare that this REACH Declaration Form is truthful and complete.
All products that we have delivered to XYZ company comply with the
requirements of the REACH “ Restriction Substances List” in its latest
valid edition. Furthermore, we will provide XYZ company with safety data
sheets should this be requested.
In case of any change, I will immediately inform and update the
information
Conclusion
Get technical assistance from experienced service providers to

Check if the product is an article or not
Evaluate if there is an intentional release of any chemical during

use of article
If there is no intentional release, check for the SVHC in the article
If no SVHC, keep the records/certificate that prove no SVHC ready

for the buyers
If SVHC present, submit Notification to ECHA
Remember, early bird catches the worm, so companies that

comply with REACH early will have lot of potential to expand
business of article export to Europe
Contact Details
For details, please visit

http://www.reach-support.com
http://www.reach-or.com
http://www.reach-onlyrep.eu
For answers to queries, please write to
rashmi@reach-support.com / advisor@reach-support.com

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REACH, substances of very high concern

(SVHC) & Articles

Dr. Rashmi Naidu

Caters to over 800 to 900 companies presently

Entire basket of REACH compliance services offered

Professionals comprise of experts who have been following REACH regulation

Offers compliance assistance services for other European regulations like

What are SVHC?

SVHC & Restricted Substances (Annex XVII of the REACH regulation)

REACH requirement for substances in article

When is a release intentional

Notification of SVHC & Notification deadlines

Undertaking/Certificates requested by the European buyers

o Pre-registration & Registration of chemicals by non-EU manufacturers

Substances of very high concern are:

Substances of equivalent concern (having endocrine

In a nutshell, extremely toxic substances shall be categorized

The list of 46 finalized SVHC can be found at

Restrictions on the Manufacture, Placing on the Market and

An object which during production is given a special

Examples furniture, clothes, vehicles, computer, toys etc.

Paint Spray Fire Car Thermo-

Obligation Conditions Type of chemicals

Registration Intentional release > All chemicals

Notification > 0.1% w/w and > 1 SVHC

Communication < 0.1 % w/w and < 1 SVHC

If there is an intentional release, exporters should calculate

Intentional release should not be confused with accidental release

The information to be notified includes the following:

• The identity and contact details of the producer

For substances included in the SVHC list before 1 December

For substances included in the SVHC list on or after 1

Communicate to the recipient of the article with sufficient

as a minimum, the name of the substance”

No tonnage limit (i.e. also applies below 1 tonne/year)

Get technical assistance from experienced service providers to

Evaluate if there is an intentional release of any chemical during

If no SVHC, keep the records/certificate that prove no SVHC ready

Remember, early bird catches the worm, so companies that

For details, please visit

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