Assent Compliance Guide for 2011 REACH/RoHS

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RoHS II, CLP & REACH
A Guide for 2011
assent ComplianCe

Jonathan hughes
pHone: 613.290.8044
Jon.HugHes@assentComplianCe.Com

Custom solutions for ComplianCe [ reaCH | roHs | Cpsia | rsl | prop65 ]

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INTRoduCTIoN To ASSENT CoMPLIANCE


assent ComplianCe
• Consulting
• Global Requirements
• Compliance Strategies
• Regulatory Interpretations and Impacts
• IT
• Cloud Computing
• Application Design
• Operations
• Program Implementation
• Data Management

Custom solutions for ComplianCy [ reaCH | roHs | Cpsia | rsl | prop65 ]

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AgENdA


• RoHS II
• CLP
• REACH
• 2011 timeline
• Q&A


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 RoHS II
legislation overview
• The recast of the RoHS Directive (RoHS II) was approved in
November of 2010.
• No new substances have been immediately added to the scope of
the RoHS Directive.
• There is a process for adding new substances. 4 substances are up
for review for addition to RoHS within a maximum of 3 years:
• HBCDD
• DEHP
• BBP
• DBP
• Additional substances can be added in the future


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 RoHS II (CoNT’d)
• All current exemptions are included in the Recast
• RoHS will now be a part of the CE Marking Directive
• This will create a uniform approach to Technical Documentation
and Declarations of Conformity.
• Products in scope of CE may not necessarily be in scope of RoHS
• RoHS Declaration of Conformity format is now outlined in the
RoHS Recast.
• Product number
• Manufacturer name
• Product info
• Declaration statement
• Etc
• Must be translated into language of member state where product is
placed on market or made available


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• All actors in a supply have the legal responsibility to inform the Member
state National Authority if they discover a non-compliant product.
• Products must then be withdrawn from the market, recalled or have
corrective measures implemented to ensure compliance.
• Information and documentation must be provided to a National
Authority upon request.
• Manufacturers and distributors must keep a register of all non-compliant
products and product recalls.


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• There are Specific requirements for withdrawal from market:
“Manufacturers who consider or have reason to believe that a EEE which
they have placed on the market is not in conformity with this Directive
immediately take the necessary corrective measures to bring that EEE
into conformity, to withdraw it or recall it, if appropriate and immedi-
ately inform the competent national authorities of the Member States in
which they made the EEE available to that effect, giving details, in par-
ticular, of the non-compliance and of any corrective measures taken;”
• Recall means any measure aimed at achieving the return of a product
that has already been made available to the end user
• Withdrawal means any measure aimed at preventing a product in the
supply chain from being made available on the market.


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 RoHS II—SCoPE
sCope CHanges
• Applies to all electrical equipment
• Most exemptions from RoHS I are still in place (military, auto, large
scale stationary and fixed, etc)
• Medical Devices are in scope 3 years from entry into force
• In-vitro Medical Devices will be in scope 5 years from entry into force
• Monitoring and control instruments – 3 years from entry into force
• Industrial Monitoring and control instruments – 5 years from entry
into force


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 RoHS II
timeline
• RoHS II takes affect on the 20th day after publication in the EU
Journal.
• Should be publish within the next 2 months. Could be as early as
this month
• RoHS is a Directive not a Regulation—Individual Member states
must pass National Legislation at least 18 months after that date.


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 RoHS II
Business impaCts
• Enforcement is much more formal and RoHS must be addressed by
manufacturers and their downstream users:
• Legal responsibility to notify national authority means no more
internalized or private corrective action
• Mandatory product withdrawal
• Registry of product recalls
• 4 new substances have been delayed and must follow a similar process
to SVHCs for inclusion to RoHS II.
• Substances will very likely pass through this process (they did for
REACH) and will be on RoHS II within 3 years at the most.
• Incorporation of RoHS II into the CE mark means a failure on RoHS
will invalidate your CE mark—this is a stop shipment issue.
• Manufacturer’s must make sure their RoHS program is accurate and not
merely a paperwork exercise.
• Downstream user’s must establish the importance of RoHS II with
their suppliers and write it into T&Cs (if they have not already).


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 CLP
• CLP aligns existing EU legislation to the United Nations Globally
Harmonised System (GHS).
• CLP contributes to the GHS aim that the same hazards will be
described and labeled in the same way all around the world.
• Under the CLP regulation, a company must notify the European
Chemical Agency (ECHA) of hazardous substances it imports on
their own or in mixtures above 0.1% by weight.
• The deadline was January 3rd, 2011 for products currently placed
on the market.
• 1 month after product is placed on the market for products placed
on the market after December 2010.


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 CLP
sCope
• Who this applies to:
• Importers or manufacturers of substances over one (1) ton per
annum into the EU
• Importers or manufacturers of substances classified as hazardous
under CLP and placed on the market—irrespective of the
tonnage (no one (1) ton limit).


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 CLP
Business impaCts
• How will this affect my company?
• You must either notify your substances in scope with the
ECHA or make sure someone in your supply has covered you
in their notification
• Covers substances that were pre-registered for REACH but
have a deadline of 2013 or 2018.
• Includes substances imported at a volume less than 1 metric
ton per annum

• What if I missed the deadline?
• Contact your supply chain—has anyone already covered you
with their CLP notification?
• Contact a service provider to see what your options are.


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 REACH
svHC BasiCs
artiCle 33 – sourCe of ComplianCe requirement:
Duty to communicate information on substances in articles:
1. Any supplier of an article containing a substance meeting the criteria in
Article 57 and identified in accordance with Article 59(1) in a concen-
tration above 0,1 % weight by weight (w/w) shall provide the recipient
of the article with sufficient information, available to the supplier, to
allow safe use of the article including, as a minimum, the name of that
substance.

2. On request by a consumer any supplier of an article containing a sub-
stance meeting the criteria in Article 57 and identified in accordance
with Article 59(1) in a concentration above 0,1 % weight by weight
(w/w) shall provide the consumer with sufficient information, available
to the supplier, to allow safe use of the article including, as a minimum,
the name of that substance.

The relevant information shall be provided, free of charge, within 45 days
of receipt of the request.


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What Does this mean?
• Once a substance has been added to the SVHC List, you must declare
its presence to your downstream users if the concentration is above
0.1% of your products weight.
• This is to be done upon immediately for professional customers and
within 45 days from request for consumers.Contact a service provider
to see what your options are.


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 REACH
Current svHC Candidate list
Link to the SVHC Candidate List:
http://echa.europa.eu/chem_data/authorisation_process/
candidate_list_table_en.asp

• Currently at 46 substances
• New additions planned every 6 months
• Any substances contained in products at a level greater than
0.1% w/w must be communicated to downstream users imme-
diately for B2B relationships and the information needs to be
made available within 45 days for consumers (the public).


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 REACH
most reCent additions to tHe Candidate list
suBstanCe Cas # eC # Common uses
2-Ethoxyethanol 110-80-5 203-804-1 Solvent and chemical intermediate

2-Methoxyethanol 109-86-4 203-713-7 Solvent, chemical intermediate and additive for fuels

Used in the manufacture of catalysts, production of
Cobalt di (acetate) 71-48-7 200-755-8 other chemicals, surface treatment, alloys, pigments,
dyes, rubber adhesion, and feed additive.

Used in the manufacture of catalysts, production of
other chemicals, surface treatment, alloys, pigments,
Cobalt (II) carbonate 513-79-1 208-169-4
dyes, rubber adhesion, and feed additive. coat frit)
and other chemicals and used as a feed additive.

Used to manufacture catalysts and other chemicals,
Cobalt dinitrate 10141-05-6 233-402-1
used in surface treatments and batteries.

Manufacture of catalysts and driers, surface treat-
ments (such as electroplating), corrosion preven-
Cobalt (II) sulphate 10124-43-3 233-334-2 tion, production of pigments, decolourizing (in
glass, pottery), batteries, animal food supplement,
soil fertilizer, and other chemicals

Used for metal finishing and as fixing agent in
Chromium trioxide 215-607-8 1333-82-0
waterborne wood preservatives.

Acids generated from chromium
Substances are generated when chromium trioxide
trioxide and their oligomers: 1) 231-801-5 1) 7738-94-5
is dissolved in water. Consequently, the uses of these
1) Chromic acid 2) 236-881-5 2) 13530-68-2
substances are the same as indicated for chromium.
2) Dichromic acid


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 REACH
future additions to tHe svHC list
Here is an excerpt from ECHA’s press release on March 25, 2010
regarding REACH:

“Accelerating addition of substances to the Candidate List:
Both Commissioners expressed disappointment at their con-
firmation hearings at the low number of SVHCs that had
been placed on the REACH Candidate List for authorisation.

They revealed that they had discussed the matter at length with
ECHA and had secured the agency’s commitment to a “roadmap” that
would allow another 106 “top priority” substances to be added to the
Candidate List by 2012. ECHA indicated that this was the maximum
number of substances it felt it could administer without compromising
on the quality of assessment.”
Link:
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/360&format=
HTML&aged=0&language=EN&guiLanguage=en


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 REACH
autHorisation overview
• The Authorisation process
• Starts with the identification of SVHC’s by Member State
Competent Authorities or the ECHA
• Preparation & Submission of Annex 15 dossiers.
• Decisions on prioritisation of these SVHCs and the sub-
sequent release of the final list of substances subject to au-
thorisation is decided by the Commission.
• Industry has to apply to the ECHA for authorisation for uses of
these substances.
• After an approval process, the holder of an authorisation can use
and place on the market the substance for the uses he was grant-
ed an authorisation.
Summary
Substances on the current SVHC List will eventually require an
Authorisation for their use on a per substance, per company, per use basis.


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 REACH
tHe aim of autHorisation
• As per article 55 of the REACH Regulation: “…the good functioning
of the internal market while assuring that the risks from substances of
very high concern are properly controlled and that these substances are
progressively replaced by suitable alternative substances or technologies
where these are economically and technically viable”.
• All Authorisation applicants shall analyse the availability of alterna-
tives, consider their risks, and the technical and economic feasibility
of substitution.
• If the risk is not adequately controlled, an authorisation may still be
granted if it is proven that the socio-economic benefits outweigh the
risks and there are no suitable alternative substances or technologies.


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 REACH
autHorisation proCess
1. Registry of intentions – Intention to submit dossier
2. Submission of Annex XV dossier (SVHC Dossier) to ECHA for
Compliance Check
3. Publication of Annex XV dossier (once it has passed compliance check)
4. After Commenting periods – Candidate List
(Article 33 Requirements kick in)
5. Prioritisation list – Order in which substances will be reviewed
for Authorisation
6. Authorisation List – Restrictions and Authorisations handed out


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 REACH
svHC Candidate list addition timeline


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 REACH
standard ComplianCe metHodologies
• Testing method
• Wet chemical testing for substances on the SVHC list

• Declaration method
• Businesses ask suppliers if their materials contain
SVHCs.
• Use responses as proof of REACH compliance


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 REACH
advantages disadvantages

• Testing method • Testing method
• Direct • High cost per test
• Conclusive • Must be redone every revision
• Declaration method • Declaration method
• Lower cost • Significant human resource
• Can cover entire time is expended
product line • Updates & supplier responses
must be constantly tracked
• Info needs to be merged with
existing PLM/ERP systems


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 REACH
Business impaCts
• Business is the current driver of SVHC compliance through
Product Specifications and RFP’s.

• Eventually, any company whose products end up in the EU will
have to completely disclose the SVHC status of all their products.

• ECHA guidance states that supply chain communication must be
documented in order to demonstrate REACH compliance.

• Notifications are to begin this year—you must obtain your SVHC
information in order to complete any necessary Notifications


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 PRACTICAL APPLICATIoNS
ideal qualities of a deClaration of Conformity
• A declaration should ideally be part of a process that keeps all your
information current and your declarations consistent.
• Upon request, you should be able to show the following items:
• Who sent the declaration (person, not just company)?
• What was the exact response?
• When was it sent?
• How (email, ftp, snail mail)?

• What was asked of the supplier on the Declaration?
• When?
• How?
• How these declarations are stored?
• How they are verified?
• How/when they are updated?


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Consulting serviCes
• Manage the compliance to ROHS, REACH, CLP and other
Environmental standards
• Ensure compliance with regulatory agencies and compliance regulations
• Review and evaluate environmental requirements and changes as published
by regulating bodies
• Support sourcing and selection of electronic and mechanical components
• Serve as subject matter expert on regulatory matters
• Specification and drawing review for compliance
• Obsolescence management and part substitution
• Work with suppliers on corrective actions

More experience and less cost than hiring a full time component engineer.


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 SERvICE offERINgS
software
• Automatically gather data environmental compliance data from your
supply chain (Declarations, COC’s, DOC’s, etc.)
• Platform for suppliers to enter environmental compliance information
• Generate custom reports based on gathered compliance data:
• Allows for a top level view of compliance progress or a drill down
to product or part level compliance
• Instantly isolate problem areas based on products, parts or materials.
• Generate compliance documents for Enforcement agencies and downstream users.
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make internal declarations based on obtained information:
• Engineering Override
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ronmental regulations
• Free model for large cap companies looking to implement a software
platform with their supply chain


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 QuESTIoNS?
Please submit your questions in writing using the Q&A tool along the
top menu tool bar.

Any questions not addressed during the Q&A portion of this webinar
will be addressed in private correspondence after the webinar.


Assent Compliance Guide for 2011 REACH/RoHS

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