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

Compliance Obligations on Exporters

Shrirang BhootAsst. General Manager (Technical Services)

REACH Support, INDIA

http://www.reach-support.com

About REACH Support

Most sought after, one of its kind helpdesk in India 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 offered Providing Assessment & Certification services to various article

exporters Professionals comprise of experts who have been following

REACH regulation since the draft stages

Contents 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’ 2010Second REACH deadline will on 31st May’ 2013o As per the ECHA’s enforcement calendar, compliance of the articles with REACH will be enforced by the end of this yearo REACH compliance documentation essential for customs clearance o Certification from a European legal entity preferredo Certification can only be provided after assessment of the company’s supply chain

Articles within REACHDefinition

“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 articlesAccordingly 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

SVHC & Restricted Substances (Annex XVII) of REACH

ECHA has finalized 53 SVHC till date The complete list can be found at www.echa.europa.eu www.reach-or.com

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 >5 mg/kg (0,0005 %) of the weight of the toy or part of toy cannot be placed on the EU market.

• 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 > 0.1% by weight of the plasticised material cannot not be placed on the EU market

• bis (2-ethylhexyl) phthalate (DEHP); CAS No. 117-81-7• 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 toys)

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 use

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 (Contd..)

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 following:

• The identity and contact details of the producer of article• The registration number (s) for the SVHC, if available • 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 substance”

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

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 applicable

If any SVHC is found to be present, check out for the thresholds

See if there are Notification or Communication requirements

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 packaging

How to calculate the SVHC thresholds (EXAMPLE)

Intentional Release

Consider a scented doll containing chemical lotion

Wt of 1 doll 100 gmWt of chemical in this doll 10 gmAmount of chemical that shall be intentionally released 06 gmNumber of dolls exported to Europe (1 calendar year) 10,000Total 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 innerwear

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 gmWt of chemical in this cuddly toy 20 gm%wt/wt 6.66%wt/wtCuddly toys exported to Europe (1 calendar year) 10,000 piecesTotal 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 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 ECHAConduct testing only for confirmatory purposes

Contact Details

For further details, my contact

Shrirang Bhoot

http://www.reach-or.com

shrirang@or-reach.com and shrirang@reach-support.com