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REACH, articles and substances of very high concern (SVHC)


REACH, articles and substances of very high concern (SVHC) Compliance Obligations on Exporters Shrirang Bhoot Asst. General Manager (Technical Services) – PowerPoint PPT presentation

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Title: REACH, articles and substances of very high concern (SVHC)

REACH, articles and substances of very high
concern (SVHC) Compliance Obligations on
Exporters Shrirang Bhoot Asst. General Manager
(Technical Services) REACH Support,
INDIA http//
About REACH Support
  • Most sought after, one of its kind helpdesk in
  • Functions as the technical support centre of SSS
    (Europe) AB
  • Clientele spread across Asia, Europe and growing
    steadily to other places
  • Caters to over 800 companies presently
  • Entire basket of REACH compliance services
  • Providing Assessment Certification services to
    various article exporters
  • Professionals comprise of experts who have been
    following REACH regulation since the draft stages

  • REACH in a nutshell
  • Why is REACH compliance important
  • Articles within REACH
  • REACH Toys, Accessories and Embellishments
  • SVHC Restricted Substances (Annex XVII of the
    REACH regulation)
  • REACH requirement for substances in article
  • Notification obligation Notification deadlines
  • Communication Obligation
  • Importance of supply chain communication
  • Case examples

REACH In a nutshell
  • REACH - Registration, Evaluation, Authorization
    and Restriction of Chemicals
  • This regulation requires information to be
    submitted to the European chemical agency (ECHA)
    on the properties of chemicals (exported as such)
    as well as chemicals contained in articles
  • For exporters of chemicals, the major compliance
    process is REGISTRATION
  • For exporters of articles, the compliance process
    is NOTIFICATION (though not in each case)

Why is REACH Compliance Important
  • First REACH deadline for high volume chemicals
    was 30th Nov 2010
  • Second REACH deadline will on 31st May 2013
  • As per the ECHAs enforcement calendar,
    compliance of the articles with REACH will be
    enforced by the end of this year
  • REACH compliance documentation essential for
    customs clearance
  • Certification from a European legal entity
  • Certification can only be provided after
    assessment of the companys supply chain

Articles within REACH
  • Definition
  • 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
  • Toys are considered as articles within REACH as
    they come in various shapes design imparting
    various functionalities

REACH - Accessories Embellishments
Accessories include a variety of articles like
Buttons, Zippers Zippers Sliders, Rivets,
Buckles, Beads, etc Embellishments include
Flat metal embellishments, stone embellishment,,
etc If accessories and embellishments are
exported as such to Europe, they will be treated
individually as articles Accordingly other REACH
obligations also have to be complied with
Substances of very high concern (SVHC) (these
are only the listed chemicals finalized by the
technical experts of the European Member States
based upon irrefutable scientific evidence of
SVHC hazard)
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, substances very toxic to the human
    health and environment shall be categorized as

SVHC Restricted Substances (Annex XVII) of REACH
  • ECHA has finalized 53 SVHC till date
  • The complete list can be found at
  • 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
  • Annex XVII entry into effect from June 2009

Some restricted substances in toys
  • Toys or parts of toys containing the
    concentration of benzene (CAS No. 71-43-2) in the
    free state gt5 mg/kg (0,0005 ) of the weight of
    the toy or part of toy cannot be placed on the EU
  • Textile or leather toys and toys which include
    textile or leather garments cannot be placed on
    the EU market if the toy or its dyes parts
    contain Azocolourants and Azodyes which release
    certain restricted aromatic amines above 30 mg/kg
    (0,003 by weight) during use.
  • Toys and childcare articles containing following
    phthalates in a concentration gt 0.1 by weight of
    the plasticised material cannot not be placed on
    the EU market
  • bis (2-ethylhexyl) phthalate (DEHP) CAS No.
  • dibutyl phthalate (DBP) CAS No. 84-74-2
  • benzyl butyl phthalate (BBP) CAS No. 85-68-7
  • Childcare articles containing Dioctyltin (DOT)
    compounds cannot be placed on the EU market
    after 1 January 2012 if the concentration of DOT
    is greater than the equivalent of 0,1 by weight
    of tin.

REACH Requirements for Toy Exporters
  • There are essentially three requirements
  • 1. Pre-registration Registration of chemical
    released intentionally from the article during
    normal or foreseeable conditions of use provided
  • Release is intentional (e.g. perfume from the
  • Intentional release Deliberate and contributes
    to an added value of the article
  • Chemical (which is released) is present in
    greater than one ton in the export consignment
    (per annum)
  • The substance has not been registered for that

Examples of intentional release from Toy
  • Scented toys Fragrance chemicals added to
    provide freshness and good smell

Pre-registration/registration seem highly
unlikely for the majority of the toy exporters,
except for similar cases as above.
If there are such requirements applicable Can
be discussed on case by case basis
REACH Requirements for Substances in Article
  • 2. Notification of SVHC if
  • SVHC is greater than 0.1 wt by wt (1000 ppm) and
    tonnage of SVHC exceeds 1 ton per annum in the
    annual exports of apparel to Europe
  • 3. Communication of SVHC if
  • SVHC is greater than 0.1 wt by wt (1000 ppm) in
    article but less than 1 ton per annum
  • Toy exporters need to confirm Notification or
    Communication obligations based upon a technical
    assessment of the chemical used in their entire
    production chain

Notification Requirements to the ECHA
  • The information to be notified includes the
  • The identity and contact details of the
    producer of article
  • The registration number (s) for the SVHC, if
  • The identity of the SVHC (s) like name of the
    substance, CAS, EINECS No, etc
  • The classification of the SVHC, which will be
    available from the Agency
  • A brief description of the use (s) of the SVHC
    in the article and of the uses of the article (s)
  • The tonnage range of the SVHC, 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 If
Notification applies but has not been done, it is
mandatory to complete the Notification before
exporting article to avoid penalties 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 in candidate list
Communication Requirements to the ECHA
  • The recipient of the article with sufficient
    information to allow safe use of the article
    including, as a minimum, the name of the
  • Only for SVHC on the Candidate List
  • No tonnage limit (i.e. also applies below 1
  • REACH Article 33(2)
  • Consumers can request the same information. The
    information should be provided within 45 days,
    free of charge.

Dyes/Pigments used in Toys
  • What to look out for

Establishing the chemical identity (proper
chemical name) Look out for the presence of SVHC
in the dye and restriction conditions
applicable If yes, determine the quantity present
in the dye (light to dark shades) Preliminary
estimations suggest that the thresholds mentioned
in REACH will not be exceeded In exceptional
cases, even if thresholds are exceeded, exporter
needs to submit NOTIFICATION to ECHA This
completes the REACH obligations and the same dye
can be used for dyeing
Accessories Embellishments
  • What to look out for
  • Identify the metallic and chemical inputs
  • Check for the SVHC and restriction conditions
  • If any SVHC is found to be present, check out for
    the thresholds
  • See if there are Notification or Communication
  • If yes, proceed with the Notification
  • Get a REACH compliance certificate and continue
    with the same supply chain

Importance of supply chain communication
If the entire production chain is in-house, get
the supply chain inventorized for all chemical
inputs If certain operations like
dyeing/printing are outsourced, ask for the
details of the chemicals used in these operations
and make a note of the same For the accessories
and embellishments used in the toys, ask the
suppliers for the raw materials used in their
production If the suppliers cite confidentiality
as the reason for not sharing the details, share
with them the SVHC list request them to give
you an undertaking that none of the SVHC is used
PLEASE REMEMBER It is very important to get
the entire supply chain scanned for the chemicals
used during production of the export article
(finished and packed toys)
Is PACKAGING an article? YES
The toys can be packaged in cardboard boxes,
plastic bags, paper, etc. Packaging is
considered as a separate article within
REACH Exporters also have obligation to check
for SVHC and restricted chemicals in
packaging Important to check the chemical used
like paints, etc used to mark the packaging If
an SVHC is present, the obligations for the
packaging would be the same as for the
toy However, if the packaging ends up as waste
in Europe, no separate obligation exists for the
How to calculate the SVHC thresholds (EXAMPLE)
Intentional Release Consider a scented doll
containing chemical lotion Wt of 1 doll 100
gm Wt of chemical in this doll 10 gm Amount of
chemical that shall be intentionally released 06
gm Number of dolls exported to Europe (1 calendar
year) 10,000 Total wt of the annual
export 10,00,000 gm (1000 kg) Total
quantity that shall be intentionally released
60 kg Intentional release quantity less than
1000 kg or 1 ton. Thus NO PRE-REGISTRATION
REGISTRATION obligation of the exporter of this
How to calculate the SVHC thresholds (EXAMPLE)
No Intentional release but SVHC present
Consider a cuddly toy containing Cobalt
dichloride, an SVHC used as mordant dye Wt of 1
cuddly toy 300 gm Wt of chemical in this
cuddly toy 20 gm wt/wt 6.66wt/wt Cuddly
toys exported to Europe (1 calendar year) 10,000
pieces Total wt of the annual export 30,00,000
gm (3000 kg) Total quantity of chemical in
the annual export 200 kg Thus NO NOTIFICATION
obligation (since total quantity is less than 1
ton per annum) but obligation of COMMUNICATION
since wt/wt exceeds 0.1 (6.6)
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
  • Registration, Export declaration, SDS, etc.
  • Substance in Article with gt 0.1 SVHC
  • Info in supply chain SDS eSDS
  • Substance in Articles with gt 0.1 SVHC gt 1 tpa
  • Info in supply chain SDS / eSDS
  • Notification to ECHA
  • Conduct testing only for confirmatory purposes

Contact Details

For further details, my contact Shrirang Bhoot
Thank You!
Questions are Welcome