Assent Compliance Environmental Compliance Ebook

ASSENTCOMPLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044

ASSENT EbOOk
a guide for 2011

cusTom soluTions for compliance [ reacH | roHs | cpsia | rsl | prop65 ]
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TAbLE OF CONTENTS
Introduction .............................................................................................................................................. 03

Kubler Ross Model of Compliance ........................................................................................................... 04

REACH in 2011 ........................................................................................................................................ 07
What is REACH? ................................................................................................................................... 08
SVHC Basics .......................................................................................................................................... 09
REACH SVHC Authorization Lists ......................................................................................................... 10
Fulfilling SVHC Obligations ................................................................................................................... 11
Authorization ........................................................................................................................................ 12
Standard Compliance Methodologies ........................................................................................................ 13
Advantages/Disadvantages ....................................................................................................................... 14
Business Impacts ..................................................................................................................................... 15
Practical Applications .............................................................................................................................. 16
Case Study in REACH Compliance .......................................................................................................... 17

RoHS – RoHS 2 in 2011 ........................................................................................................................... 23
Legislation Overview ............................................................................................................. 24, 25, 26, 27
Scope ..................................................................................................................................................... 28
EU Declaration of Conformity ................................................................................................................ 30
Presumption of Conformity and Enforcement ............................................................................................ 31
EU Parliament Issues, What to Do ........................................................................................................... 32
RoHS Past, Present, Future ..................................................................................................................... 33

CLP in 2011 .............................................................................................................................................. 36
Legislation Overview, Scope .................................................................................................................... 37
CLP 101 ................................................................................................................................................ 39

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INTrOduCTION
Assent Compliance is proud to bring you a compliance guide for 2011. This Ebook has been developed by the
Assent Compliance team consisting of our industry leading consulting division, our IT developers and our project
managers. Our goal is to leave readers well informed on compliance trends, keep readers up to date on what indus-
try leaders are doing and provide a well researched road map for compliance in 2011.

Assent Compliance also hosts regular webinars, publishes weekly blog posts and speaks to companies and industry
organizations on a regular basis. This Ebook has also combined much of our outbound and inbound educational
resources to give readers interesting real world compliance content.

Upon conclusion of reading if you have any questions or comments with any content contained within this Ebook
please contact the Assent team at info@assentcompliance.com.

On behalf of all the Assent Compliance team,

Thank you for reading and all the best in your on-going compliance efforts.

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kübLEr-rOSS GrIEF MOdEL
of environmenTal compliance requiremenTs

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kübLEr-rOSS GrIEF MOdEL OF ENvIrONMENTAL
COMPLIANCE rEquIrEMENTS
Assent Compliance global consultants have seen North American businesses react to REACH environmental regu-
lations in a manner not unlike the Kübler-Ross grief model. The five company stages break out as follows:

1. Denial – an outright denial by some companies to acknowledge that this regulation can affect them. While
the majority of companies are beyond this stage, it’s still a prevalent sentiment –about 25 percent.

2. Anger – any change from the status quo in a large organization may cause anger in those burdened with
extra work. This can undoubtedly cause internal frustration with regard to means of compliance, budget
decisions and plans for moving forward. During this early planning stage, companies have trouble making
decisions and typically seek advice – about 30 percent.

3. Bargaining – with any legislation there can be exemptions, addendums or clauses that may absolve a party
of some portion of their responsibility. This is not typically the case for REACH. Although the “bargaining”
stage is not prevalent, it does occur in some companies – about 5 percent.

4. Depression – typically a company will tender several requests for consultants to make suggestions and to
better inform internal stakeholders on instituting a compliance process or system. Although this phase does
not effect the organization as a whole, the compliance team itself frequently feels incapable of undertaking
the task either due to perceived understaffing or adverse impact by their supply chain. This stage is more of
a “micro” state, which follows the organization’s acceptance of REACH requirements – about 20 percent.

5. Acceptance – once organizations accept the reality that environmental regulations are real, enforce-
able and can affect their bottom line, the typical response is an “Alright, let’s do it” approach – about 20
percent. As one Assent client noted: “Has our business model changed? No? If our business model includes
selling our products globally then we’re going to comply with environmental regulations. It’s simple. We’re
not afraid of challenges at this company.”

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At Assent we encounter companies at all stages. It is important to note however, whatever stage your company may
be at, this need not be a painful, expensive or largely time consuming process if executed with the right partners.
We just have to:

1. Identify your obligations
2. Put a plan / system in place
3. Execute

While it is naive to think that in a large company the process is as simple as the three steps outlined but for the
most part in a company large or small complying with REACH, RoHS/RoHS II , CLP and other environmental
regulations can be done quickly and effectively with the right partners.

Where is your company in the K-S Stages?

assenT provides:
• Software Solutions for Environmental Compliance (RoHS, RoHS II, REACH, CLP etc)
• RoHS, REACH, WEEE Consulting
• Engineering Assessments
• Custom Solutions and Support
• General Sustainability Consulting

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rEACH IN 2011

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WHAT IS rEACH?
quick overview of THe regulaTion
Registration, Evaluation, Authorization and Restriction of Chemicals

• Regulation (EC) No 1907/2006,
• Initial regulation was over 700 pages
• Several thousand additional pages of guidance

• Administered by the European Chemical Agency (ECHA)

Requires industry to be responsible for the safe manufacture and use of chemical substances

• Manufacturers/Importers must Evaluate and Register substances
• Awareness of substances of very high concern (SVHC)
• Restrictions on chemicals posing unacceptable risk

Obligations for nearly all products, parts, substances and mixtures manufactured or imported in the EU

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SvHC bASICS
svHc = subsTance of very HigH concern
C = Carcinogenic
REACH Definition
M= Mutagenic
• Substances such as CMRs, PBTs, vPvBs and endocrine disrupters
R = Reproductive Toxin
• Responsibilities for products containing an SVHC:
P = Persistent
1. Identification in MSDS documents
B = Bioaccumulative
2. Communication obligations to customers (articles w/ >0.1%)
T = Toxic
3. Notification obligations to ECHA
vP = very Persistent
• w/ >0.1%, over 1 tonne per year
vB = very Bioaccumulative
4. Authorizations required to continue using after sunset date

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rEACH SvHCS
How are THe svHc candidaTe and auTHorizaTion lisTs creaTed?

Proposal for SVHC
Consultation
Restrictions
(EU member states)a
and Review January 14, 2009

april 14, 2009
Consultation
SVHC Candidate
Review
List
Prioritize June 1, 2009

2012+
Draft Priority
Consultation
SVHC
and Review
Substances
ocTober 28, 2008

Authorization List
(Priority Substances Sunset Date
added to Annex XIV)

Communicate Info Notification of Authorization to
on Candidate Candidate SVHCs use Annex XIV
SVHCs to to ECHA SVHC
customers (June 1, 2011) after sunset date

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FuLFILLING SvHC ObLIGATIONS?
communicaTion – reacH arTicle 33

applies To all arTicles
manufacTured/imporTed To THe eu

if svHc presenT > 0.1%

manufacTurers/imporTers - inform cusTomers of (minimum):
• cHemical name
• informaTion on safe use

consumers may requesT informaTion abouT THe
presence of svHc in arTicles
(musT reply wiTHin 45 days)

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AuTHOrIzATION
subsTances lisTed in reacH annex xiv
Annex XIV has List of Substances subject to Authorization

• Manufacturers/Importers/Downstream users must receive authorization to continue
using these substances

Have until the “Sunset Date” to receive authorization

• Must be submitted at least 18 months before Sunset Date
• Authorization request requires details on which use(s) the authorization request covers

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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 time is
• Can cover entire expended
product line • Updates & supplier responses must be con-
stantly 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 demon-
strate 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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ASSENT COMPLIANCE
2010 case sTudy

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SuMMAry
clienT summary: HigHligHTs
The client associated with this project is a leading • 35% compliant with strictly passive requests.
aerospace technology provider with a market capi- (1 month)
talization of over 3 billion dollars. They have a glob- • 72% compliant with 2nd passive request and
al outreach and are considered innovative leaders in limited direct contact / information (within 3
the compliance space. months of launch.)
proJecT purpose: • $0.00 spent in Testing Costs.
Ensure an enterprise size product is backed by a • Foundation/Precedence Set for All Future
REACH compliance process in order to be able to Requests and Products Added to Database
comply with RFP. (Requests for proposal).
• Elimination of Reliance on Wet Chemical Testing
proJecT scope:
• Installation of Assent Software and Set Up.
• Database Size: 30 000 parts
• Supply Chain: 250 unique suppliers
• Import of BOB to Database and
Data Integrity Verification
• Supply Chain Engagement
• Data Collection (phase 1 passive, phase 2 active)
• Reporting

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GOAL ACHIEvEMENT
Having achieved 72% of all required declarations for the product with continued contact with the THE ASSENT
CLIENT supply chain represents risk mitigation and a REACH compliance system. This is representative of suffi-
cient effort / success to be able to answer and win RFP competitions THE ASSENT CLIENT is currently working
towards and or already currently awarded.

This program has been deemed a success by management on all levels inclusive of the sales division through to the
VP and CEO level.

After completion of the first simulator as a pilot program THE ASSENT CLIENT has committed to using Assent
for ALL products being sold into the EU with 27 new products being brought on board and an alternate division
of the company using Assent as its REACH compliance program supplier.

Any reliance and cost of testing has been removed as part of the THE ASSENT CLIENT compliance mandate
which has in turn reduced costs at present and will exponentially reduce costs moving forward.

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CASE STudy
A lesson in procuring documentations from your supply chain.

In July 2010, THE ASSENT CLIENT undertook a new REACH compliance program using Assent’s REACH
SVHC Compliance Software. The goal of this program was to sufficiently mitigate the risk of SVHCs being con-
tained in their product without proper communication and notification to downstream users. These goals needed
to be achieved in order to meet contractual obligations in the EU and prevent losing the EU as a viable market due
to business requirements (IE: the pushback of REACH obligations by THE ASSENT CLIENT customers).

(In this specific instance RFP’s in the EU could not be won without a REACH program in place)

THE ASSENT CLIENT and Assent created a program based on 3 principles from which to base the compliance
program:

• ECHA recommended approach
• Current Industry Practice
• Expected enforcement methodology

Multiple sources were used to for guidelines for each of the principles above:

ecHa recommended approacH:
ECHA Guidance on requirements for substances in articles (Version 2.2):
http://guidance.echa.europa.eu/docs/draft_documents/Draft%20Guidance%20on%20requirements%20
for%20SiA_CARACAL.pdf ”http://guidance.echa.europa.eu/docs/draft_documents/Draft%20Guidance%20
on%20requirements%20for%20SiA_CARACAL.pdf

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Section 2.5 - Documentation
Section 5.1 - Information via the Supply Chain
Section 5.2.1 – Difficulties of chemical analyses
Section 5.2 – Chemical analysis of substances in articles

currenT indusTry pracTice:
Aerospace
Boeing’s REACH position with suppliers: http://www.boeingsuppliers.com/environmental/reach.html

Airbus REACH requirements outlined in RFPs

Electronics Industry
Schneider-Electric’s REACH/RoHS approach:
http://www.schneider-electric.com/sites/corporate/en/products-services/reach-rohs-compliance/substances.page

expecTed enforcemenT meTHodology:
Current REACH Enforcement program – REACH Enforce-1:
http://www.echa.europa.eu/doc/about/organisation/forum/ref_1_facts_report.pdf ”http://www.echa.europa.eu/
doc/about/organisation/forum/ref_1_facts_report.pdf

Other restricted substance enforcement methodologies - UK RoHS 2010 enforcement report:
http://www.rohs.gov.uk/Docs/Enforcement%20Annual%20Report%202009-2010.pdf
http://www.rohs.gov.uk/Docs/Enforcement%20Annual%20Report%202009-2010.pdf

Based on the sources and guidelines cited above, THE ASSENT CLIENT and Assent designed a program that
would assess and document potential risk of THE ASSENT CLIENT articles containing SVHCs. Once this as-
sessment was complete, THE ASSENT CLIENT suppliers were prompted to login to a web-based portal hosted
by Assent where the suppliers could make declarations for the parts they supplied THE ASSENT CLIENT which
were in scope of the program.

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Training and education was provided to suppliers by Assent. The system used by Assent Compliance was simplified
and streamlined, allowing for mass or individual declarations to be submitted to the system by suppliers.

After receiving 30 minutes of training on Assent’s system, suppliers took an average of less than 5 minutes to
complete their declarations. Declarations were targeted for verification based on response and risk level (identified
previously).

After the first run through, THE ASSENT CLIENT received a response rate of approximately 35%. The remaining
suppliers who had not responded were then separated into 2 separate groups:

• Suppliers with the most number of parts left unchecked in the system.
• Suppliers with the heaviest and/or highest risk parts left unchecked in the system.

All suppliers were then sent a second notification from THE ASSENT CLIENT outlining the need for action and
the possibility of loss of sales if this request was not met. In parallel, the 2 groups mentioned above were contacted
personally by Assent and THE ASSENT CLIENT together in order to emphasize the importance of their compli-
ance with these requirements.

The current level of response is at 72% and rising. It is fully expected that the overall response rate will exceed at
least 90% by November including over 90% of high risk parts. This will allow for the sufficient mitigation of risk
of non-compliance as per the goals of the program according to its guidelines.

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roHS & roHS II IN 2011

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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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rOHS II (CONT’d)

• 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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rOHS II (CONT’d)

• 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 con-
formity, to withdraw it or recall it, if appropriate and immediately inform the competent national authorities of
the Member States in which they made the EEE available to that effect, giving details, in particular, 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

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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Eu dECLArATION OF CONFOrMITy
The manufacturer must draw up and have available an EC Declaration of Conformity that states the product satisfies the
requirements of the RoHS substance restrictions and that the fulfillment of these restrictions has been demonstrated.

“Where the compliance of an EEE with the applicable requirements has been demonstrated by that
procedure, manufacturers shall draw up an EC declaration and affix the CE marking”

“Manufacturers shall keep the technical documentation and the EC declaration of conformity for
ten years after the EEE has been placed on the market.”

“By drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for
the compliance of the EEE.”

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PrESuMPTION OF CONFOrMITy ANd ENFOrCEMENT
presumpTion of conformiTy
• “Member States shall presume electrical and electronic equipment bearing the CE marking as conforming to
this Directive.”
• Electrical and electronic equipment, which have been tested in accordance with harmonized standards, shall be
presumed to comply with all the relevant requirements of this Directive to which such standards relate.

enforcemenT
• Stronger language for purposes of enforcement.
• Requires EU Member States to enforce the requirements of the Directive
• Requires economic operators to maintain documentation of conformity.
• Requires economic operators to identify suppliers and customers to market surveillance authorities if requested.

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Eu PArLIAMENT ISSuES
Among the Members of the European Parliament, contention remains over several important issues including:

• Whether to expand the directive to all electronic products
• Solar panels?
• Whether to conduct an impact assessment before expanding scope
• Whether to include all brominated and chlorinated flame retardants
• Whether to include polyvinyl chloride (PVC)

WHAT TO dO?
a summary
• Still a “PROPOSAL”

• Re-assess product scope.
• Stronger market surveillance mechanisms will provide enhanced enforcement on “grey area” products

• For Medical Devices and Monitoring and Control Instruments, begin to make conversion decisions and plans

• If you do not have restricted substance control (RSC) measures in place, they need to be created

• Existing RSC measures should be reviewed

• Consider RoHS requirements together with REACH SVHC obligations

• Investigate substitution options for the 4 substances currently under review.

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rOHS: PAST, PrESENT…FuTurE
We have certainly come a long way since July 1, 2006 when the EEE industry was introduced to the Restriction of
Certain Hazardous Substances (RoHS). In the four years that have passed, RoHS has been debated and opposed,
accepted and overdone, enforced and neglected, and most importantly, continually changed.

From the very moment that RoHS was introduced, the question was asked: “how will enforcement be carried out by
authorities?” Just how did the country authorities expect to monitor and enforce a law that pushed the boundaries
of how EEE was designed and manufactured when there were so many exemptions and areas of uncertainty? The
answer to this question has been apparent over the past 4 years – it won’t.

At least not by country authorities.

The truth is that the industry itself is responsible for the majority of RoHS enforcement, with many large manufac-
turers keeping tight control on their supply chain and keeping auditing/due diligence in-house with their own XRF
and wet-chemical test facilities. Japanese industry took RoHS to a higher level with the adoption of JGPSSI (Japan
Green Survey Standard Initiative) that required suppliers to comply with RoHS and a multitude of other substance
restrictions and declaration requirements. With big names such as NEC and Sony enforcing JGPSSI, RoHS was
being mandated through non-legislative channels and the fallout for being exposed as non-compliant (and subse-
quently dropped as a supplier) was/is massive. This was only the beginning.

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From its inception, industry was really split in their approach to RoHS. While some big names decided to ignore
material declaration and compliance, others went in the complete opposite direction. If Lead, Cadmium, Mercury,
Hexavalent Chromium and PBB/PBDE were of such a concern to authorities, what were the next items to follow?
From this was born the industry trend toward internal RSL (restricted substances list) development and enforcement.
Any manufacturer of EEE components/subassemblies reading this article will know that the days of single digit RSL
lists are gone. What was once 6 substances now ranges into the hundreds ,depending on the company, and covers
much more than RoHS and REACH. It seems that the only real consistencies for restricted substances are:

• Enforcement is industry driven
• Restrictions vary by company
• Change is constant
• Compliance declaration is largely homogeneous (no pun intended) across industries

If the last 4 years are any indication, industry will continue to lead restricted substances enforcement.

Now, taking a look at the NMO (National Measurement Office of the UK) RoHS enforcement report from the
past year (April 1 2009 through March 31 2010), we see that the long anticipated summary of action is largely
indirect. No stories of non-compliances resulting in penalty or prosecution are highlighted, no aggressive initiatives
are stated and the reader is simply left to comply by the governance of industry and look to the enforcement agen-
cies for educational resources. That is to say that the NMO talks about the “indirect approach” to RoHS enforce-
ment, which is founded on the “belief that most UK industry would aim to operate in a lawful manner and would
therefore work towards full compliance”.

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The following is the summary of “direct” enforcement by the NMO. Of particular interest are the 10 warning let-
ters, 0 cautions and 0 prosecutions. Stacking these up next to a single global manufacturer with thousands of sup-
pliers and the business impact of enforcement by being dropped from a preferred supplier list, the NMO has not
really enforced anything.

Between April 1 2009 and March 31 2010, the NMO:

resoluTions Type no.

Investigations 326

Resolution after initial engagement (1) 143 Compliant Business

Resolution requiring direct intervention (2) 158 Administrative resolution

Improvement plans 6

Compliance Notices 5

EU Notifications 2

Product Withdrawals/quarantines 2

Warning letters 10

Simple cautions 0

Prosecutions 0

In summary, RoHS, REACH and RSL lists in general are here to stay. The authorities create the requirements and
the industry enforces them.

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CLP IN 2011

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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.

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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CLP 101 – yOu’vE bEEN ASkING.
At Assent we always look forward to answering your regulatory questions. Once the same question is asked more
than a hand full of times it is more than just a question, it’s a trend. Recently we’ve been asked on almost a daily
basis about CLP under the REACH regulation.

For this post we have attached a brief summary and link as well as touched on some of the ways that Assent
Compliance helps companies comply with CLP through a combination of software tools and world class consulting.

clp 101
The CLP regulation sets the rules for classification and labeling of chemicals. It aims to determine whether a sub-
stance or mixture displays properties that lead to a classification as hazardous.

CLP itself does not set information requirements (except for determining physical properties). The information
requirements laid down in REACH will however, ensure availability of much data.

Once such properties are identified and the substance or mixture is classified accordingly, manufacturers, im-
porters, downstream users and distributors of substances or mixtures, as well as producers and importers of
certain specific articles (explosive articles which are subject to classification according to Part 2 of Annex I to
CLP) should communicate the identified hazards of these substances or mixtures to other actors in the supply
chain, including to consumers.

The hazard of a substance or mixture is the potential for that substance or mixture to cause harm. It depends on
the intrinsic properties of the substance or mixture. In this connection hazard evaluation is the process by which
information about the intrinsic properties of a substance or mixture is assessed to determine their potential to cause
harm. In cases where the nature and severity of an identified hazard meets the classification criteria, hazard clas-
sification is the assignment of a standardized description of this hazard of a substance or a mixture causing harm to
human health or the environment.

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Hazard labeling allows for the communication of hazard classification to the user of a substance or mixture, to alert
the user to the presence of a hazard and the need to avoid exposures and the resulting risks.

CLP sets general packaging standards, in order to ensure the safe supply of hazardous substances and mixtures.

wHaT do THese cHanges mean for you?
If you supply a chemical, you should:

• Make sure you understand what your duties are under the new CLP Regulation. You will have duties if you:
import, manufacture, formulate, mix, distribute, or sell chemicals.

• Make sure you understand the transitional periods to ensure that you re-classify, label and package on time.

• Cooperate with others in your supply chain, to make sure the changes are managed smoothly.

• Check that your chemicals are correctly classified and that your product labels are accurate.

Source: http://ec.europa.eu/enterprise/sectors/chemicals/classification/how-does-clp-work/

Further reading on the subject: http://ec.europa.eu/enterprise/sectors/chemicals/files/ghs/clp_introduction_en.pdf

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ASSENTCOMPLIANCE

wHaT can assenT do ?
Our team of IT developers, engineers and REACH consultants have developed a module in Assent Compliance
Suite as well as provide expert guidance for companies with CLP requirements. If you think you may have CLP
requirements and are unsure about any compliance related issue feel free to contact Assent anytime and we would
be happy to provide a free assessment. (www.AssentCompliance.com)

did you know?
Assent Provides:

• Software Solutions for Environmental Compliance
• RoHS, REACH, WEEE Consulting
• Engineering Assessments
• Custom Solutions and Support
• General Sustainability Consulting

[ 41 ]

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