Assent Compliance - 2013 REACH Registrations

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info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931

REACH – RegistRation 2013 is
not the only RequiRement,
aRe you Ready foR the
next 2 yeaRs?
assent compliance

Krystal Noseworthy-BaKer
phone: 613.882.1429
krystal.baker@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
• Recent ECHA Releases • CLP Overview
• Data Sharing – Rulings and Reports • Requirements

• Registration Overview • Timelines
• Requirements • Process
• Timelines • FAQs
• Process • Impacts
• FAQs • Implementation Timelines
• Impacts • Common Industry Practices
• Authorisation Review
• Q&A


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 REgISTRATION – RECENT ECHA RELEASES
First Report Card was released July 1, 2011
• Examined the lessons and challenges encountered so far (3 years into
REACH, 2 years into CLP). Dealt with everything from nanomateri-
als to joint registration to IT tool support
• Communication, feedback, process, comitology all need to improve
response time, there are no issues with the quality of response simply
how quickly the information is getting up and down the chain
• Enforcement guidance and processes will hopefully be clarified and released

Green MEP Satu Hassi (European Parliament Environment Committee
liaison) and the ECHA
• Discussion on SVHCs
• Discussion on compliance checks and making dossiers better (= more
time-consuming)


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There are currently 4416 registrations with 20175 registration numbers having
been granted (there were over 143 000 pre-registrations)
Registration dossiers for intermediates are not up to the necessary standards
http://echa.europa.eu/news/na/201105/na_11_21_intermidiates_en.asp
• The ECHA screened over 400 dossiers and found the majority do not
meet the conditions necessary to benefit from the reduced information
requirements for intermediates
• The ECHA is placing onus on the registrants to reassess and
update as required


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07 Mar 2011 – Completeness checks completed by ECHA as required
http://echa.europa.eu/news/na/201103/na_11_08_echa_meets_completeness_
check_deadline_en.asp
• 15366 dossiers relevant to the 2010 deadline were submitted in the 2
months leading up to the deadline
• It is ECHA’s duty to undertake a completeness check on these within a
three month period which ended on February 28th, 2011 – The deadline
was met by the ECHA.

On a separate REACH note:
SDS Guidance was officially published September 7th, 2011


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 dATA SHARINg – RuLINgS ANd REPORTS
Multiple Registrants, Same Substance
• August 10th, 2011
http://echa.europa.eu/news/na/201108/na_11_33_same_substance_reg-
istrants_20110810.asp

• Companies have submitted registrations without taking part in a single
Substance Information Exchange Forum (SIEF)


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 REACH – REgISTRATION 2013
overview
• Applies to substances produced or imported into the EU at ≥100 tonnes per year
per manufacturer or importer.

• Greater number of substances is expected to be registered in 2013 than in 2010.

• The total data requirements for ≥100 tonne substances are less than those for the
≥1000 tonne substances.

• Unfortunately because these substances have smaller tonnages, they are less
widely used which means it is more than possible that less data will be available
to fulfill the REACH dossier information requirements.


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• This may mean there is increased use of alternative methods for filling data
gaps, (read-across, Quantitative Structure Activity Relationships (QSARs),
new testing or the creation of testing plans.)

• The biggest help to dossier completion are SIEFs (Substance Information
Exchange Forums) and Consortiums – Letters of access to the dossiers and
information they have already gathered are essential for proper completion
of data requirements. The cost of letters of access is determined by the num-
ber of registrants so it is important to investigate this as soon as possible.


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 REACH – REgISTRATION 2013
requirements
• Information Requirements are established in Annex VII, VIII and IX of the
REACH Regulation: Standard Information Requirements for Substances
Manufactured or Imported in Quantities of 1 Tonne or More, 10 Tonnes
or More and 100 Tonnes or More
• Sections 4-7 of the IUCLID Dossier are where the informational increase
is concentrated
• As you move from one tonnage level to another, the registration dossier in-
formation requirements increase however theses annexes also establish the
rules for any adaptation from the information requirement


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REACH – REgISTRATION
timeline

Registration
Registration Registration > 1 tonne
LOA Access
> 1000 tonnes, TODAY
Letter and >= 100 tonnes Registration
OMRs, R50-53 SEptEmbER JunE 1, 2012
Reception of JunE 1, 2013 < 100 tonnes
21, 2011
Dec 1, 2010 Lead Dossier
JunE 1, 2018

Collection, Completion
Locate and verification
appoint Only of Section 1.4 Entry of
and entry Testing
Representative of all remaining
if required. UV data into
necessary IR
existing dossier.
NMR
dossier data. MS TCC Dossier
HPLC Submission
GC


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REACH – REgISTRATION
process

Substance Review

YES Gather Gather Dossier
Active SIEF and Is there an active Gather Identify Data
membership Instructions Gather Data as
Consortium SEF or Corsortium? membership data Gaps
process. Gather and Substance necessary
Investigation and costs Sections 1 & 3
LoA. Dataset
nO

Identify Data Complete Dossier
Data Gathering Gaps
Sections 1 – 13
TCC
Gather data as
necessary
Submit Dossier

Complete Dossier

TCC

Submit Dossier


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 REACH – REgISTRATION
faqs
• What if there is no lead registrant?
• What if I already have an Only Representative?
• What happens if we do not meet the 2013 Deadline?
• Once we have registered is there anything else we will need to worry about?


AS SENTCOM PLIANCE

 IMPACTS – REgISTRATION 2013
REACH COMPLIANCE
• Customs Stoppages
• Delivery Delays or Rejections
• New Product Launch delays
• Fines
• Imprisonment
• Loss of business
• REACH compliance is quickly becoming a contractual obligation and
if the obligation cannot be met then potential customers move on


AS SENTCOM PLIANCE

 CLASSIfICATION, LAbELINg + PACkAgINg (CLP)
overview – classification
• Regulation (EC) No 1272/2008
• GHS (Global Harmonised System) Based
• Impacts the classification of substances, mixtures, including:
• Safety Data Sheets
• Packaging
• Labelling
• CLp Classification Deadlines:
• Substances: 1 December 2010
» If already on the market before 1 December 2010 1 December 2012
• mixtures: 1 June 2015
» If already on the market before 1 June 2015 1 June 2017
• CLP SDSs
• Deadlines for SDSs (AND LABELS), same as classification deadlines


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 CLASSIfICATION, LAbELINg + PACkAgINg (CLP)
overview – notification
• CLp notification Scope:
• Substances subject to registration under REACH
» Unless already registered (during 2010 registration) with the CLP
classification included

• Substances classified as hazardous under CLP and placed on market
» IRRESPECTIVE OF TONNAGE

• Substances classified as hazardous under CLP and in a mixture above
concentration limits (Annex I CLP, or in DPD) which results in mixture
being classified as hazardous and the mixture is placed on the market


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• CLp notification Deadlines:
• Substances on market 1 December 2010: January 3rd, 2011
• Substances on market after 1 December 2010: 1 month from date of
placement on market

• ORs have no role under CLP
• Notification to match Registration
• Harmonised classification published – Notification to be updated
• 14 mar 2011 –
http://echa.europa.eu/news/na/201103/a_11_10_rac_opinions_clh_20110314_en.asp

• 15 June 2011 –
http://echa.europa.eu/news/na/201106/a_11_27_rac_adopts_ten_scientific_opinions_en.asp


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 CLP
notification process

Without testing time
included, normally
takes 2-4 weeks
(Very Data Dependent)

Have you completed
notifications for Collection, OptImAL:
Decide on Completion of
hazardous substances verfication and Confirm Substance Completion TCC
Notification Section 1.4 Testing
and all substances under entry of all Identity already and Submission
Submitter UV
the scope of REACH? necessary existing entered of dossier
(EU Entity) IR
dossier data
NMR
MS
HPLC
GC


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 CLP
timeline

CLP
Classification CLP Classification CLP Classification
(Substances) TODAY CLP Classification
Transition Transition
Dec 1, 2010 SEptEmbER (Mixtures)
(Substances) (Mixtures)
21, 2011 June 1, 2015
December 1, 2012 June 1, 2017

CLP Notifi cation
January 3, 2011


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 CLP
faqs
• My products are all mixtures, do my SDSs have to have CLP classification
information on them?
• I registered my substances before the 2010 deadline but I am not sure if the
CLP information was included?
• My substance is under the 1 tonne threshold for REACH so I did not
notify for CLP, should I have any concerns?


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 CLP
impacts
• At this time, the primary impact is customs stoppages.
• It is very obvious when substances do not meet the CLP requirements
Example: Formaldehyde
DSD
Classification : Carc. Cat. 3; R40 – T; R23/24/25 – C; R34 – R43
Risk Phrases : + R23/24/25 : Toxic by inhalation, in contact with skin and if swallowed.
: + R34 : Causes burns.
: + R40 : Limited evidence of a carcinogenic effect.
: + R43 : May cause sensitization by skin contact.
Safety Phrases : + S1/2 : Keep locked up and out of the reach of children.
: + S26 : In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice.
: + S36/37/39 : Wear suitable protective clothing, gloves and eye/face protection.
: + S45 : In case of accident or if you feel unwell, seek medical advice immediately
(show the label where possible).
: + S51 : Use only in well-ventilated areas.
Symbol(s) and
Indication(s) of Danger
+ T:

continued...


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(cont’d)
Example: Formaldehyde
DSD
Specific Concentration Limit(s)
Concentration Classification

C ≥25 % T; R23/24/25

5 % ≤ C < 25 % Xn; R20/21/22

C ≥25 % C; R34

5 % ≤ C < 25 % Xi; R36/37/38

C ≥ 0,2 % R43


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 CLP
impacts (cont’d)
CLp
REguLATION (EC) NO 1272/2008 ANNEx VI TAbLE 3.1
classification labelling

Hazard Class and Hazard Statement pictogram Signal Hazard Statement
Category Code(s) Code(s) Word Code(s) Code(s)
Carc. 2 H351 H351
Acute Tox. 3 * H331 GHS06 H331
Skin Corr. 1B H314 Dgr H314
Skin Sens. 1 H317 H317

SPECIfIC CONCENTRATION LIMITS ANd M fACTORS
concentration
C ≥25 %
5 % ≤ C < 25 %
5 % ≤ C < 25 %
C ≥ 5 %
C ≥ 0,2 %


AS SENTCOM PLIANCE

PICTOgRAMS

Skull & Crossbones Health Hazard Corrossion


AS SENTCOM PLIANCE

 REACH ANd CLP
timeline review
Questions & Answers on Regulation (EC) No 1272/2008 on classification,
labeling and packaging of substances and mixtures:
REACH Pre-registration First phase Second phase Third phase
entry into period in deadline in deadline in deadline
force December 1, 2010 June 1, 2013 June 1, 2018
June 1 to
June 1, 2007 December 1, 2008

all new substances and
substances and
reach substances mixtures ≥ 1000
mixtures ≥ 100 tonnes substances and mixtures ≥ 1 tonne per year
timeline and tonnes per year or of
per year
mixtures very high concern

year 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
onwards

classified,
labelled and packaged
under dsd. if clp is classified under both dsd and clp;
substances applied in full as well, labelled and packaged under clp.
classified, labelled and packaged under clp.
clp no dsd labelling and
timeline packaging.

classified, labelled and packaged under dpd. if clp is applied in full as well,
mixtures no dpd labelling and packaging.

CLP entry into Obligation to Obligation to apply CLP to mixtures. Please note that for certain
force; repeal of apply CLP to substances/mixtures in the 2012/2017 deadline for re-labelling and
Annex I to DSD substances re-packaging applies
January 20, 2009 December 1, 2010 June 1, 2015


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 COMMON INduSTRy PRACTICES – REACH & CLP
• Registration: Only Representative Nomination
• Registration – Joint Dossier: REACH Centrum is a commonly used SIEF
and Consortium administrative firm with established processes, contracts, and
LoAs
• CLp Classification: In-house chemical assessment based on defined CLP thresh-
olds (within regulation) OR Third Party assessment based on testing results
• CLp notification: Importer of record/manufacturer provides information to
Third party for completion and submission of dossier on their behalf


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 AuTHORISATION REVIEw
• The Authorisation process – starts with the identification of substances of
very high concern (SVHC) by Member State Competent Authorities or the
European Chemicals Agency (on behalf of the European Commission) by
preparing a dossier in accordance with Annex XV.
• Decisions on prioritisation of these SVHCs and the subsequent release
of the final list of substances subject to authorisation is decided by the
Commission.

• Each Authorisation:
• identifies the substance,
• provides it’s “properties of very high concern”,
• makes clear both the Sunset Date and the Application Date
• includes the review period and the exempted uses or categories of uses,
if applicable


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• SVHC Candidate List substances will most likely ALL eventually be on the
authorisation list
• Applicable to imported substances on their own or in preparations.
• Substances being an integral part of articles are NOT subject to
authorisation

• Applicable to all substances manufactured in the European Union


AS SENTCOM PLIANCE

 AuTHORISATION REVIEw (CONT’d)
• Authorisation Applications (dossiers) are created in IUCLID (same as
REACH Registration dossiers and CLP notification dossiers)
• They are NOT submitted in REACH-IT, they use a webform via the
ECHA website
• They include a CSR , an alternatives analysis, a socio-economic analy-
sis and a substitution plan

• Applications must be submitted 18 MONTHS before the sunset date
• Application creation should start at least 30 MONTHS (2.5 YEARS)
before the sunset date
• You will see on the next slide that the sunset dates are in 2014 and 2015:
» Application deadlines starting February 2013 – February 2014
» Application creation process should start February 2012 –
February 2013
• What is the alternative?
• REDESIGN


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 REACH – AuTHORISATION
current authorisation list

substance included in annex, sunset date

4,4’ – Diaminodiphenylmethane (MDA) In Annex XIV – Sunset Date Aug 21, 2014

Dibutyl phthalate (DBP) In Annex XIV – Sunset Date Feb 21, 2015

Benzyl butyl phthalate (BBP) In Annex XIV – Sunset Date Feb 21, 2015

Bis (2-ethyl(hexyl)phthalate) (DEHP) In Annex XIV – Sunset Date Feb 21, 2015

5-tert-butyl-2,4,6-trinitro-m-xylene (musk
In Annex XIV – Sunset Date Aug 21, 2014
xylene)

Hexabromocyclododecane (HBCDD)and
In Annex XIV – Sunset Date Aug 21, 2015
all major diastereoisomers identified:


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 RECOMMENdEd fOR AuTHORISATION
recommended for inclusion dec 17, 2010

substances

Diarsenic pentaoxide Diarsenic trioxide

Alkanes, C10-13, chloro (Short Chain
Chlorinated Paraffins) 2,4-Dinitrotoluene
*Recommendation for inclusion June 1, 2009

Diisobutyl phthalate (DIBP) Lead chromate

Lead chromate molybdate sulphate red (C.I. Lead sulfochromate yellow (C.I.Pigment Yellow
Pigment Red104) 34)

Tris(2-chloroethyl)phosphate


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 dRAfT RECOMMENdATION fOR AuTHORISATION
comment deadline sept 14th

substances

Cobalt dichloride Sodium dichromate

Ammonium dichromate Chromic acid

Oligomers of chromic acid and dichromic
Dichromic acid
acid

Chromium trioxide Cobalt(II) carbonate

Cobalt(II) diacetate Cobalt(II) dinitrate

Cobalt(II) sulphate Potassium chromate

Potassium dichromate Sodium chromate

Trichloroethylene


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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 - 2013 REACH Registrations

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