Welcome

ESMA HSEP Meeting

07 November 2014

1. Apologies, arrangements2. Maters arising3. Approval last meeting report4. Report Actions previous meeting

Overview meeting actionsCLP Information Note for Customers Confirm posted on website and circulated

to Marketing Promotions CommitteeGeneral Manager

Stencil remover classification proposal. Members confirmed agreement with classification

Peter Gower provide final example Peter Gower

NVC reclassificationEach 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

Prepare simplified guidance for members Chairman/ALL

Global ‘REACH’ Regulation Tabulate main requirements for new systems

Chairman/ALL

GHS differences 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.

ALL

Toy Safety Directive Review and report prior next meeting, due to time limitations

Chairman

Sustainability Members identify important topics as they arise for inclusion in the Agenda

ALL

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 SheetsESMA REACH ENFORCE-2ESMA Check List

Quality Safety Data Sheets

REACH around the Globe

Region/Country Responsibility Inventory What PolymersVolume exemption?

Australia Importer Australian Inventory Chemical Substances (AICS)

Substances not listed on AICS

Yes 100 Kg with Annual reporting requirement

Canada          China Manufacturer;

Importer; ORInventory Existing Chemical Substances (in) China (IECSC)

New substances not listed on IECSC

Yes No

Europe Manufacturer; Importer; OR

REACH All substances Under review

1 tonne

South Korea Manufacturer; Importer; OR

  New substances/targeted existing

   

Malaysia          Philippines          Switzerland          USA  Importer/Exporter  TSCA  All substances  Yes  No

• 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

Printed Articles: UV curing

LeadArsenicAntimonyCadmiumManganeseChromiumSelenium

Barium

Mercury

EN71-3:1995 – 9 Elements

AluminiumAntimonyArsenicBariumBoronCadmiumChromium IIIChromium VICobaltCopper

LeadManganeseMercuryNickelSeleniumStrontiumTinOrganic TinZinc

EN71-3:2013 – 19 Elements

2014/15 Work Plan

HSEP Seminar

19th March 2015, Mallorca

Presentation topics & Speakers to be decided

Brief Report of Board Activities – ESMA Chairman

Registration

Restriction

CoRAP, SVHC, Roadmap

(Endocrine disruptors)

Authorisation

Enforcement

Guidance

SIN List

REACH Regulation

• 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

REACH: Polymers

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”

NMP Restriction Proposal

• 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

Restriction – NMP use only if

CoRAP Ongoing2015-2017 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/smart-regulation/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 31http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0895&from=EN

• 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

• 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

REACH: EN-FORCE- 3

Safety data sheets and Exposure Scenarios

ECHA eGuide

http://view.pagetiger.com/ECHAeGuide1-1/Issue1

ECHA produced as part of Chemical Safety Report/Exposure Scenario Roadmap activity

Separate page for each of the 16 sections SDSHelp with exposure scenariosIncludes

Key points Closer look – more detailed information

eGuide

• 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

eGuide additional support

SIN List

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

ATPs

Harmonised C & L

Poison centres

Outer labelling

Multi-lingual labelling

CLP Regulation

Member discussion if required

CLP Labelling Mixtures

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

CLP Regulation - ATPs

Already harmonised - Phthalates, BPA, NMP

Harmonised C & L

Substance CLP DSD Status

2-butoxy ethanolCAS # 111-76-2

Acute tox 3: H311; H331

T: R23/24 Intention

Propane-1,2-diolCAS # 57-55-6

STOT SE 3; H335   Intention

FormaldehydeCAS # 50-00-0

H331; H311; H301; Skin Corr. 1B; H314, Skin sens. 1 – H317+ muta 2; H341+ carc 1A; H350

T: R23/24/24;Muta. Cat 3; R68; Carc. Cat. 1; R45

Agreed

n-ethyl pyrrolidone,CAS # 2687-91-4

Repro. 1B; H360d T; R61 Agreed

• 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)

• 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

Poison Centres (PC) cont/d

CLP - Article 33

Supply label on outer if no transport label & CLP label on inner packaging are not clearly visible

Issue has caused some debateDUCC* position: no CLP label required on consolidated

packageOthers disagreeCLP lack of definitions

Inner, intermediate, outer. etc.Raised for discussion at CARACAL

Seems to be support for DUCC position

*Downstream Users Co-ordination group

Multi-lingual labels

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

Substances: n-vinyl caprolactam

EuPIA Technical Committee (ETC) Oct Meeting Update position statement:

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

Food packagingCosmetic RegulationPrior Informed Consent RegulationTransport

Legislation, other

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

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 Non-Food 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

• 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

Food Packaging governance (2)

(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

Cosmetic Regulation

(EU) 649/2012Export notifications

(importing countries outside EU)Import notifications from non EU CountriesApplies to substances and mixturesIndustrial chemicalsPesticides (including biocides)

Prior Informed Consent Regulation

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

• 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 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

ECHA: Prior Informed Consent (2)

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 TitleWaste Framework Directive 2008/98/EC

End-of-life vehicles (ELVs) Regulation 2000/53/EC

Waste Electronic and Electrical Equipment Directive (WEEE)

2012/19/EU

Restriction of Hazardous Substances Directive (in EEE)

2011/65/EU

Packaging & Packaging Waste Directive 94/62/EC

Batteries Directive 2006/66/EC

Seveso III Directive 2012/18/EU

Energy Efficiency Directive 2012/27/EU

Biocidal Products Regulation 528/2012

Environment

Biocidal Products RegulationWEEE/RoHSEnergy 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”

In can preservatives – PT6Not a biocide product

No claim for external biocidal effect= treated article

Antifouling paints, fungicide in wood preservativeIs 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.

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.

UV Curing Lamps - LED

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

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