Welcome
ESMA HSEP Meeting
07 November 2014
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Apologies, arrangements
Maters arising
Approval last meeting report
Report Actions previous meeting
Overview meeting actions
CLP Information Note for Customers
Stencil remover classification proposal.
Members confirmed agreement with
classification
NVC reclassification
Each company to manage in keeping with their
organisation policy
Safety Data Sheets: Revision to REACH Annex
II and complaints from members regarding
quality of information provided
Global ‘REACH’ Regulation
GHS differences
Confirm posted on website and circulated General Manager
to Marketing Promotions Committee
Peter Gower provide final example
Peter Gower
Prepare simplified guidance for members
Chairman/ALL
Tabulate main requirements for new
systems
Prepare starter document of differences
for circulation and review
Chairman/ALL
Printed articles: UV curing inks migration issues Review literature and report back for next
meeting. Overdue requires investigation
and reporting for Autumn meeting.
Toy Safety Directive
Sustainability
Chairman/All
ALL
Review and report prior next meeting, due Chairman
to time limitations
Members identify important topics as they ALL
arise for inclusion in the Agenda
Food packaging and Cosmetics Regulation
Include as topics for the next meeting
Chairman
HSEP Seminar March 2015
Commence discussion on ideas, topics
and format
Chairman/All
Quality Safety Data Sheets
 Quality Safety Data Sheets
 ESMA
 REACH ENFORCE-2
 ESMA Check List
REACH around the Globe
Region/Country
Australia
Canada
China
Europe
South Korea
Malaysia
Philippines
Switzerland
USA
Responsibility
Importer
Inventory
Australian
Inventory
Chemical
Substances
(AICS)
Manufacturer;
Importer; OR
Inventory
Existing
Chemical
Substances
(in) China
(IECSC)
REACH
Manufacturer;
Importer; OR
Manufacturer;
Importer; OR
Importer/Exporter TSCA
Volume
What
Polymers exemption?
Substances not Yes
100 Kg with
listed on AICS
Annual reporting
requirement
New substances Yes
not listed on
IECSC
No
All substances
Under
review
1 tonne
Yes
No
New substances/
targeted existing
All substances
Printed Articles: UV curing
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Broad subjects
• Food packaging
• Cosmetics packaging
• Toys
• Brands requirements
Essentially migration likely
Minimised with low migration inks
Must comply with specific requirements
Now covering food packaging issues
Cosmetics/toys
Other applications to be raised as required
EN71-3:1995 – 9 Elements
 Lead
 Barium
 Arsenic
 Mercury
 Antimony
 Cadmium
 Manganese
 Chromium
 Selenium
EN71-3:2013 – 19 Elements
 Aluminium
 Lead
 Antimony
 Manganese
 Arsenic
 Mercury
 Barium
 Nickel
 Boron
 Selenium
 Cadmium
 Strontium
 Chromium III
 Tin
 Chromium VI
 Organic Tin
 Cobalt
 Zinc
 Copper
2014/15 Work Plan
HSEP Seminar
19th March 2015, Mallorca
Presentation topics & Speakers to be decided
Brief Report of Board Activities – ESMA Chairman
REACH Regulation
Registration
Restriction
CoRAP, SVHC, Roadmap
(Endocrine disruptors)
Authorisation
Enforcement
Guidance
SIN List
REACH: Polymers
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Review of Polymers - Article 138(2) REACH
2nd Stage of review in process finalised December 2014
Main aim to determine whether some polymers should be
registered and build legislative proposal
Ahead of 2nd Report on effectiveness of REACH (according
to Article 117 due in 2015)
Polymer registration elsewhere not helping e.g. China
10 page Fact Sheet on each jurisdiction prepared and
evaluated
Highly likely that some polymers will need to be registered
in future
NMP Restriction Proposal
Netherlands submitted proposal, but was rejected
because did not follow necessary format
Now resubmitted proposal
“Manufacturing, and all industrial and professional
uses of the substance, where workers’ exposure
exceeds a level specified in the restriction”
Restriction – NMP use only if
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Guaranteed exposure (as 8-hr TWA) below 5 mg/m3
Peak exposures (15 min. STEL) must remain below 10
mg/m3 and must be compensated by lower exposures
during the same day in order to remain below the 8-hr TWA
value
Dermal exposure is avoided with protective clothing and
gloves, which comply with the requirements of Council
Directive 89/686/ECC or other measures
Apply hierarchy control measures
Maintain exposure monitoring program demonstrate
compliance
CoRAP Ongoing
2015-2017 just published
Titanium dioxide
13463-67-7
Methanol
67-56-1
Formaldehyde
50-00-0
Furfuryl alcohol
98-00-0
Benzophenone
119-61-9
2-ethylhexyl acrylate
103-09-3
2-methylpropan-2-ol
75-65-0
2 hydroxyethyl methacrylate
868-77-9
Dimethyl glutarate
1119-40-0
Methylmethacrylate
80-62-6
Endocrine disruptors
European Commission Road map on endocrine disruptors for
Plant Protection Products and Biocidal Products Regulation
http://ec.europa.eu/smartregulation/impact/planned_ia/docs/2014_env_009_endocrine_disruptors_
en.pdf
ECHA Working party continues to evaluate
REACH Annex XIV
 9 further substances added
 (EU) 895/2014 – 14 August 2014
 Total number of substances subject to authorisation
of use is now 31
http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32014R0895&from=EN
REACH: EN-FORCE- 3
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Focus on checking registration obligations
Manufacturers, importers and only representatives
Co-operation with Customs authorities
1st phase Feb-Aug 2013
Inspectors checked 528 companies, verifying >3000
substances
Importers main focus – information from Customs
Now analysing results for report to be published soon
REACH: EN-FORCE- 3
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86% companies fulfilled obligations
14% did not comply with some of the requirements
76% of these was non registration
20% unfilled only representative duties
Some imported substances SVHC
Penalties depended on Member State
Mainly verbal & written advice on corrective action
~ 1/3 issued Administrative Orders
Sanctions e.g. fines rarely used
ECHA eGuide
Safety data sheets and Exposure Scenarios
http://view.pagetiger.com/ECHAeGuide1-1/Issue1
eGuide
 ECHA produced as part of Chemical Safety
Report/Exposure Scenario Roadmap activity
 Separate page for each of the 16 sections SDS
 Help with exposure scenarios
 Includes
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Key points
Closer look – more detailed information
eGuide additional support
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short video tutorials;
examples for each section of the SDS & ES
a toolbox that allows the user to compare how they use the
substance with the conditions contained in the exposure
scenario
a section with answers to the most frequently asked
questions
annotated template for an exposure scenario
supplementary information and links to other relevant
sources
SIN List
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Chemsec updated to Version 2.1
Substances said to meet REACH criteria as SVHC
Mainly CMR (Chemsec)
249 additional substances/substance groups
626 substances
138 on official REACH Candidate List
REACH registration database used to update list
Includes hazard classification date, information on use
and tonnage bands
CLP Regulation
ATPs
Harmonised C & L
Poison centres
Outer labelling
Multi-lingual labelling
CLP Labelling Mixtures
Member discussion if required
CLP Regulation - ATPs
7th ATP
• 12 harmonised classifications, 21 new entries
• Defers application of 6th ATP to Jan 2016
8th ATP
• Reflects 5th revision of GHS
• Main focus is skin corrosion/eye damage classification
criteria
• Adoption expected April 2015
Harmonised C & L
Already harmonised - Phthalates, BPA, NMP
Substance
2-butoxy ethanol
CAS # 111-76-2
CLP
Acute tox 3: H311;
H331
Propane-1,2-diol
CAS # 57-55-6
STOT SE 3; H335
Intention
Formaldehyde
CAS # 50-00-0
H331; H311; H301; T: R23/24/24;
Skin Corr. 1B;
Muta. Cat 3; R68;
H314, Skin sens. 1 Carc. Cat. 1; R45
– H317
+ muta 2; H341
+ carc 1A; H350
Agreed
n-ethyl pyrrolidone, Repro. 1B; H360d
CAS # 2687-91-4
DSD
T: R23/24
T; R61
Status
Intention
Agreed
Poison Centres (PC)
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Cost-Benefit Analysis
Designed for failure?
Too many difficult cost questions and no survey of
perceived benefits!
Estimate current costs of PC Submissions
Total annual ongoing operational costs spent on PC
registrations (based on last full year) in euros
Percentage breakdown
• Data handling; Supply chain liaison; Data input; audit
One-off cost & % breakdown
Poison Centres (PC) cont/d
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Break costs down for each country
Estimated cost in Euros for new system
• Breakdown product type
Why is there a change in cost
Unique formulator Identifier
Cost in UFI System
Label/documentation
Administration
Inventory to include UFI
Cost of replacing labels
CLP - Article 33
 Supply label on outer if no transport label & CLP label on inner
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packaging are not clearly visible
Issue has caused some debate
DUCC* position: no CLP label required on consolidated
package
Others disagree
CLP lack of definitions
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Inner, intermediate, outer. etc.
 Raised for discussion at CARACAL
 Seems to be support for DUCC position
*Downstream Users Co-ordination group
Multi-lingual labels
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Discussion at ESMA – agreement to use
Not permitted according to ECHA
Labelling & Packaging Guidance
For reasons of practicality i.e. to suit supply markets
Disagreement from DUCC
Downstream User of Chemicals Co-ordination group
ECHA Guidance has no legal status
Continue with multi-lingual labels
Was expected to issue Advice Note
But appears that this is being re-considered
Multi-lingual labels - Update
Belgium Competent Authority raised at CARACAL
 Legal obligation in Belgium to label in French,
Dutch & German
No room on standard labels
 Small package exemption on all products
(Article 29 (1) CLP)
 If accepted, should open scope for wider use
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Substances: n-vinyl caprolactam
EuPIA Technical Committee (ETC) Oct Meeting
 Update position statement:
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No manufacture screen inks from end March 2015
Temporary exemption for use in Digital
(Subject to satisfactory risk assessment)
To be reviewed at subsequent ETC Meetings
Legislation, other
Food packaging
Cosmetic Regulation
Prior Informed Consent Regulation
Transport
Food Packaging
Definitions are important
Primary food contact: Print in contact with food
Secondary: (indirect): Print on reverse side of substrate in
contact with food
External: additional layer of packaging
• Katia for inclusion at ESMA
• Some members producing ‘low migration’ inks for indirect
food contact applications?
• Member inks could be used for external package printing
and labels
• Must be an effective barrier to migration (foil/glass)
Food packaging governance
Legislation applicable to printing inks
• (EC) 1935/2004
must not prevent the final package from meeting the
requirements of the Regulation – safety, taste, odour
• EC 2023/2006
‘Good manufacturing practice for materials & articles
intended to come into contact with food’ (specifically
references printing inks
• ResAP (2005)2 on “Packaging Inks Applied to the NonFood Contact Surface of Food Packaging”.
(Council of Europe Committee of Ministers of the Partial
Agreement in the Social and Public Health Field)
Food Packaging governance (2)
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ResAP (2005)2 basis of legislation in Switzerland
Swiss Ordinance +ve list (can be used)
German Ordinance (under revision & will specifically
reference printing inks)
Regenerated cellulose film (2007/42/EC)
Plastics Directive (EU 10/2011)
Brand standards e.g. Nestle
EuPIA
Cosmetic Regulation
(EC) 1223/2009
Definition: Site of application & nature of product
Includes haircare, skincare, toiletry, perfume and decorative
cosmetic products
• Katia for inclusion at ESMA
• How many ESMA members affected?
• Manufacturer/supplier duty to ensure safe for intended use
• Banned substances, restricted substances
• Substances e.g. UV filters, preservatives must be used
from authorised list
• Labelling & other duties
Prior Informed Consent Regulation
(EU) 649/2012
 Export notifications
(importing countries outside EU)
 Import notifications from non EU Countries
 Applies to substances and mixtures
 Industrial chemicals
 Pesticides (including biocides)
ECHA: Prior Informed Consent
Information now on ECHA Website
• Chemicals listed in Part 1 of Annex I are subject to the
export notification procedure
• Chemicals listed in Part 2 of Annex I subject to export
notification procedure and PIC notification procedure
• Chemicals listed in Part 3 of Annex I are subject to the full
PIC procedure under the Rotterdam Convention.
• Annex V lists the chemicals and articles the use of which is
prohibited in the European Union and which shall not be
exported
ECHA: Prior Informed Consent (2)
• In addition, other chemicals have been identified that are
also subject to the PIC Regulation, as they are members of
chemical groups which are explicitly listed in Annex I or V
• These chemicals, which are not themselves explicitly listed in a PIC
Regulation Annex, are shown in italics.
• It is possible to search for chemicals based on the Annex
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and part of the Annex they are listed under, EC and CAS
number, chemical name and use category.
It is also possible to refine the query by using multiple
search filters
http://echa.europa.eu/information-on-chemicals/pic/chemicals
Transport
UN3077 and UN3082 pack size exemption (Road, Sea & air)
“SP 375 These substances when carried in single or combination
packagings containing a net quantity per single or inner packaging
of 5 l or less for liquids or having, per single or inner packaging, a
net mass of 5 kg or less for solids, are not subject to any other
provisions of ADR provided the packagings meet the general
provisions of 4.1.1.1, 4.1.1.2 and 4.1.1.4 to 4.1.1.8.””.
Can use from 1 Jan 2015
Environmental legislation
Directive/Regulation
Waste Framework Directive
Title
2008/98/EC
End-of-life vehicles (ELVs) Regulation
2000/53/EC
Waste Electronic and Electrical
Equipment Directive (WEEE)
Restriction of Hazardous Substances
Directive (in EEE)
Packaging & Packaging Waste Directive
2012/19/EU
Batteries Directive
2006/66/EC
Seveso III Directive
2012/18/EU
Energy Efficiency Directive
2012/27/EU
Biocidal Products Regulation
528/2012
2011/65/EU
94/62/EC
Environment
Biocidal Products
Regulation
WEEE/RoHS
Energy Efficiency Directive
BPR – Treated Articles
BPR – 528/2012 from Sept 2013
“… any substance, mixture or article which has been treated
with or intentionally incorporates, one or more biocidal
products”
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In can preservatives – PT6
Not a biocide product
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No claim for external biocidal effect
= treated article
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Antifouling paints, fungicide in wood preservative
Is a biocide and must be authorised
Be careful of resins & other substances that may
incorporate biocides
UV Curing Lamps - Mercury
Mercury currently restricted to 0.1% wt EEE
under exemption in WEEE Directive to 2016
 Exemption to be reviewed in 2015
 Draft application for an extension from
"Light in Europe"
• Application should be submitted by year end
• Will be then opened for public comments.
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UV Curing Lamps - LED
LED lamp suppliers expected to challenge the
application
EuPIA will support exemption application
LED not a direct replacement for mercury lamps, but
matter of "if not when" it will be happen.
Energy Efficiency Directive
To meet the EU energy target there will be a requirement of
mandatory energy audits by large companies by December
2015. These will need to identify areas for energy
improvements. Large companies (>250 employees, > Euro
50 million or > Euro 43 million assets) have until 5 December
2015 to complete; failure will result in £50,000 fine.
Sustainability Matters
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Sustainability/Sustainable Innovation Award
proposed to the Board
Will get us thinking ‘sustainability
Hugely important to organisations
Consolidate/demonstrate what we are doing
Presentation & Awards dinner
Generate income ESMA
Views?
Autumn 2015 Meeting, date & location
Close of Meeting
Thank you