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EUROPEAN COMMISSION ENVIRONMENT DIRECTORATE-GENERAL Directorate A - Green Economy Chemicals ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Resources Based, Manufacturing and Consumer Goods Industries REACH Chemicals Industry

Brussels 19 September 2014 Doc. CA/ 72/2014 Rev. 2

SUMMARY RECORD 15th Meeting of Competent Authorities

for REACH and CLP

8 July 2014 15:30 – 17:30 (REACH) 9 July 2014 09:00 – 17:30 (REACH and CLP)

Charlemagne building Room Sicco Mansholt

Rue de la Loi 170

1000 Brussels, Belgium

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SESSION A: GENERAL ISSUES

1. ADOPTION OF AGENDA CA/34/2014

The agenda for the Open session of the 15th

meeting of the CARACAL was adopted without

modification.

2.1 DRAFT SUMMARY RECORD CA/33/2014 (CARACAL-14) & CA/02/2014

(CARACAL-13)

The summary record of the 13th

CARACAL meeting was approved. The deadline for written

comments on the summary record of the 14th

CARACAL meeting was set at 15 August 2014.

3.1 REPORT FROM THE CA SESSION

SIEF functioning

The Commission presented first ideas on how to improve the functioning of SIEFs through an

implementing act addressing transparency, dispute resolution, specific measures for SMEs for

cost sharing. Member States gave their initial reactions and will provide comments in writing.

The Commission plans to present a document for consulting stakeholders in the autumn. That

will then be discussed in the open session of CARACAL in November 2014.

Ammunition cartridges

The Commission presented reflections on whether ammunition cartridges should be

considered as articles or mixtures in a container, applying the relevant guidance. A majority

of Member States supported the position that ammunition cartridges should be seen as

articles, while a minority supported that they are mixtures in a container. Member States were

asked to coordinate with relevant Ministries and sent further comments in writing. The

Commission will prepare a document for in the open session of CARACAL in November

2014.

EOGRTS

The Commission presented a proposal for handling draft dossier evaluation decisions

concerning high tier reproduction toxicity studies, following the amendment of REACH

Annexes to replace the Two-Generation-Study with EOGRTS. The Commission proposed to

adopt decision requiring registrants to submit a new testing proposal. Member States

expressed concerns regarding the workload for ECHA and MSC and the resulting delays for

actually obtaining the data and had questions about the legal elements with regard to decisions

on compliance checks.

Strategy for compliance checks

ECHA had reviewed its policy on compliance checks and presented its proposal for a more

integrated strategy for compliance checks and other measures to prioritise the right substances

to improve dossier quality and safer use of chemicals. Member States expressed general

support, while asking for some clarifications, expressing initial reactions and announcing

further comments in writing. The intention is to present a revised paper to ECHA's

Management Board in September.

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Report from RiME

ECHA presented a proposal for the structure and content of the annual report on the SVHC

Roadmap implementation.

Member States took note of the outcome of the latest RiME meeting and, in particular

- the progress with the implementation of the SVHC Roadmap

- the importance of early discussion on RMOA's

- the progress made in aligning the workflows and documentation on screening of

substances, substance evaluation and RMOA.

One Member State introduced an initiative on how to monitor the impact of the authorisation

process, inviting MSCAs and the Commission to participate.

Conclusions and recommendations of a workshop on Authorisation

Member States were informed about the outcome of a workshop hosted by one Member State

to discuss a range of issues around authorisation, including the selection of substances for

inclusion into Annex XIV and how to streamline and simplify the authorisation process,

increase predictability, and reduce the burden for certain specific cases. The Commission

presented a paper with initial ideas on whether exemption under Art. 58(2) would be possible

or how to lay down elements for simplification for such specific cases in an implementing

Regulation. The Commission and ECHA invited Member States to nominate participants for a

task force with the mandate to work on the further development of the details for simplified

procedures.

The Commission announced that during public consultation on ECHA's draft

recommendation for prioritisation of substances for inclusion into Annex XIV, stakeholders

will also be asked to submit socio-economic elements that COM will take into account before

amending Annex XIV.

Member States gave their initial reactions and further comments will be provided in writing.

A revised paper will be presented to the open session at the next CARACAL in November

2014.

Use of Art 68(2) for CMRs in articles

The Commission and Member States discussed criteria and processes for how to use the

procedure under Art 68(2) of REACH for restricting CMRs in articles. A paper will be made

available to stakeholders in the near future. The Commission will start working on the next

case for using the Art 68(2) procedure for CMRs in textiles.

OSH Workshop

The Commission announced that a workshop on the interlinks between REACH and the

legislation on occupational safety and health (OSH) will take place on 18 November. It will

be jointly organised by all Directorates-General concerned and the Commission will invite

representatives from the competent authorities for both sets of legislation. Stakeholders will

be invited to participate at the second half of the workshop.

Report from the TTIP negotiations

COM informed about the status of the negotiations on a chemical annex in the framework of

the Transatlantic Trade and Investment Partnership (TTIP). The exchange of information on

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procedures and processes on both sides is rather complete. Reflections on how to put the

identified possibilities for cooperation into practice have started.

REACH

4.1 LOW TONNAGE STUDY – REPORT ON REVIEW OF CSA/CSR OBLIGATION

FOR CMRs – FINAL REPORT CA/57/2014 REV 1

The Commission briefly introduced the main findings of the report.

Three Member States welcomed the report. One Member State agreed that there seemed to be

a benefit to require a CSR for CMRs when registered in quantities between 1 and 10 tonnes.

One Member State asked how COM would proceed to decision making, which was clarified.

(COM explained that MS comments would be collected and then internal discussions shall

happen among ENV and ENTR to arrive at a proposal by Jan 2015).

One Member State referred to their ministry’s report on identification of CMRs by QSARs,

arriving at ~ 7 non-registered and ~ 200 registered substances, i.e. higher than the findings in

the report, which would then also increase the expected benefits. The Commission requested

to receive the report and confirmed that this would be taken into account in any next steps.

One Member States found the report very detailed and interesting, and that it seems to provide

justification for extending the obligation. But they questioned how reliable the benefit figures

really are. They stated that the quality of SDSs today is often not sufficient. They

acknowledged that the exact number of CMRs estimated is perhaps not that important as the

higher the number, the more the cost/benefit relation would shift towards a justification for a

CSR requirement.

One observer considered the report as interesting, and commented that the report explains

how CAs think about integrated testing strategies. They voiced some doubts about the

numbers reported without being more specific and noted that the identified additional

protection for man & environment is quite small. Introducing a CSR requirement into

registration would be shifting work from the larger group of Downstream Users to the fewer

shoulders of the registrants, who already have to bear a big cost.

Another observer shared the doubts on both the numbers of CMRs reported as well as on the

estimation of benefits.

One observer was positive about the report and emphasised that they consider the CSR the

main means to restrict exposure to non-threshold carcinogens. They appreciated the

conclusions drawn and hoped those would be taken forward by the Commission.

4.2 Biogas and Digestate - CA/MS/41/2014

One Member State introduced document CA/MS/41/2014 explaining that its intention was to

seek a possible harmonised approach and interpretation via-a-vis the status under the REACH

registration obligation for biogas and digestate and not to artificially extend the scope of

current Annex V entries.

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One Member State concurred that biogas was exempt from registration via Annex V. Two

other Member States stated that for them, digestate was considered non-waste (in one

Member State there were national end-of waste criteria on that). Therefore, as there is no

exemption from its registration in Annex V, they considered that digestate needs to be

registered. However, they were in favour of finding a solution to exempt digestate from

registration. They felt that the Guidance on entry V.8 already addressed a part of the question

from the first Member State and they were wondering as to whether, by analogy to compost

(resulting from an aerobic process), entry V.12 would not be the appropriate place allowing

for a digestate exemption (similar material resulting resulting from an anaearobic process).

One Member State also expressed the view that since there is no mention of the source for

biogas in entry V.12 nor in the corresponding guidance, this entry covers biogas of any origin.

One Member State, supported by another Member State, recalled that in the review of Annex

V in 2008, the issue of a possible exemption for digestate had been raised but it was decided

that entry V.12 was to cover only biogas and compost, but not the result of an anaerobic

degradation (digestate). They therefore supported the idea to now find a solution for digestate

and saw an amendment of Annex V as a possibility to allow for its exemption from

registration.

The Commission recalled that the proposal to include digestate in entry V.12 had come very

late in the review process of Annex V in 2008 and, due to lack of information it had not been

possible to assess it at that point in time. It was clear from those discussions that compost and

digestate where considered to be two different materials and hence the exemption of the

former does not imply that the latter is also exempted. The Commission did see the opening

Annex V for inclusion of digestate as a possible way forward and recalled that in any case a

correction of the references to the CLP Regulation in this Annex needed to be done in 2015.

The Commission also concurred with the view that entry V.12 covers biogas of any origin.

One observer thanked the Member State and the Commission for trying to find a solution for

this case and saw a specific exemption in Annex V as a logical solution.

Member States and observers were invited to submit their comments in writing by 15 August.

5.1 Modification of REACH Annexes to reflect scientific progress - Acute Toxicity

Testing CA/61/2014

The Commission introduced document CA/61/2014 proposing to adapt point 8.5.3 of REACH

Annex VIII to technical progress following requests made by animal welfare organisations

and earlier discussions at CARACAL.

One Member State welcomed the Commission's proposal and the approach to handling

technical details in guidance, as long as it is ensured that this guidance is sufficiently clear.

They agreed that including details in the Annexes can be problematic if new developments are

to be expected (as it is the case for acute inhalation toxicity with the fixed concentration

method). They asked for clarification in relation to the last point of the proposed additional

text for Annex VIII, which referred to non-testing methods, as such methods may not yet be

available. The Commission responded that this was intended to keep the door open to future

developments, which is expected to lead to the situation that less in vivo irritation data will be

available.

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Another Member State also agreed with the proposal, stating that they would have preferred

to see the extent of dermal absorption to be included as a criterion for testing via the dermal

route.

A further Member State welcomed the proposal which had taken into account their comments

made after the last meeting.

An observer welcomed the uptake of the proposed adaptations by the Commission. Another

observer considered the proposal as not going far enough, but expressed support for the

suggested change in order to save animals in the short term. They, however, regretted not

seeing other proposed changes included in the proposal. A further observer also thanked the

Commission for the proposal but stated that more changes in the REACH Annexes and

guidance update are needed in order to limit in vivo testing. They also considered it important

to increase SMEs' awareness of the available waiving options.

The Commission thanked Member States and observers for the positive reactions and invited

them to submit any further comments by 5 September. The Commission also explained that

work on a proposal to change the REACH Annexes in relation to skin/eye irritation endpoints

is underway, and that it intended to present a paper to CARACAL at its meeting in November

2014.

6.1 Report on the preparation of the 2018 Registration Roadmap - CA/54/2014

ECHA presented its draft 2018 Registration Roadmap, which consists of two parts: 1)

Background outlining the objectives of REACH and the role that registration of phase-in

substances plays in the REACH framework, and setting the scene for the 2018 registration

deadline which is expected to be very different from the two previous ones and 2) A series of

actions and milestones, presented from the registrants' perspective, i.e. different phases that a

registrant needs to go through to successfully register his substances from understanding

which of his substances are in the scope of 2018 registration to submitting his registration

dossier to ECHA.

The draft Roadmap was welcomed by CARACAL members and observers. In the subsequent

discussion several Member States and also observers noted that the awareness of SMEs of

their registration obligations seems alarmingly low and should be addressed. ECHA

acknowledged this, and explained that there is a separate SME awareness raising project in

the Agency. ECHA also emphasised that all actors should take responsibility in the

awareness-raising through their own channels.

One Member State noted that it would be sensible to separate all the actions to registrants for

1-10 tonnes and for 10-100 tonnes, as the problems they may encounter are likely to be

different. ECHA agreed and mentioned that also other factors such as being a lead registrant

or a member registrant are considered in the scenarios that ECHA is building for its 2018

registration preparation. This can be made more explicit in the Roadmap. Another Member

State said that ECHA should be more explicit in what is expected from the Member States.

ECHA replied that the form and type of cooperation to jointly manage the support for the

2018 registration deadline will be gradually developed based on the initial input from the

Member States CAs at this stage.

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An observer requested ECHA to clarify the scope of the Roadmap, and, when developing IT

tools also to consult large companies. ECHA mentioned that large companies are well

represented in the regular consultation on ECHA’s IT tools development, and the SME

consultation would add to this. ECHA also mentioned its new way of gathering feedback from

industry by visiting some focus groups, giving them hands-on training and discussing the

obstacles directly with the companies.

Another observer informed that they had started to gather information from their members on

their registration intentions by asking, at this stage, how many substances they expected to

register in 2018. ECHA welcomed this initiative and invited other observers to provide ECHA

with any market intelligence on the 2018 registrations as soon as they would have it. ECHA

invited written comments by 5 September 2014.

6.2 Revision of the completeness check rules - CA/45/2014

ECHA briefly introduced the document, emphasising the motivation behind the review of the

completeness check rules on the technical dossier (TCC) and the main considerations to be

taken into account in the review process. Member States were invited to provide a first

reaction on the proposed approach.

Several Member States supported the proposal. One Member State welcomed the aim to apply

the revised TCC rule set to both new and existing registrations, to ensure a level playing field

and uniform improvement of data availability. They also encouraged ECHA to make use of

lessons learned from screening work such as for isolated intermediate registrations with

incompatible uses. ECHA explained that such experience could indeed be taken into

consideration, always when in line with the legal requirements. ECHA was furthermore

encouraged to strive to ensure that existing registrations were updated with the new rule set.

Some observers voiced concerns about the high workload caused by the forthcoming upgrade

from IUCLID version 5 to version 6. ECHA clarified that all data from IUCLID 5 would be

automatically migrated to the new format, and emphasised that the update in the IUCLID

format is not directly coupled with the introduction of new TCC rules.

One Member State enquired whether ECHA had any plans to carry out manual checks on

dossiers at the TCC step. ECHA clarified that the current document focussed on the automatic

TCC rules, but that a project had been launched to investigate the feasibility of carrying out a

manual completeness check verification of certain dossier elements. Some observers

expressed their concern about such a check, particularly in relation to the substance

identification, and pointed out that according to Article 20(2), the completeness check was not

assess the quality and adequacy of information. ECHA acknowledged both views and noted

that the project for analysing the possibility of a manual completeness check was still in its

initial phase.

ECHA concluded the discussion by confirming the importance of carrying out a

proportionality analysis on the proposed new TCC rules, and encouraged observers to provide

constructive and factual input on challenges they see with the proposed IUCLID format and

the TCC rules.

6.3 Follow-up to the Substance Evaluation Workshop - CA/48/2014

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ECHA introduced the document summarising the conclusions and recommendations of the

workshop held in ECHA in May and requested Member States CAs endorsement on the

proposed conclusions.

In the discussion, several Member States expressed their support to many of the Workshop

conclusions but pointed out some issues of concern:

A Member State, supported by several others, expressed concern on the wording regarding

timing of the CORAP listing and emphasised that substance evaluation (SEV), as a concern

driven process, may necessitate inclusions of substances for earlier evaluation than for the 3rd

year. It was consequently agreed to modify the conclusion to read: "Normally Member States

should aim, where possible, to propose new CORAP candidates for the 3rd

year of CORAP

update." ECHA reiterated that nominations for the 1st or 2

nd year will eliminate or limit

ECHA's possibility to conduct a CCH on the substances, which in general should be preferred

to avoid data gaps in standard information hampering the SEV. Several Member States

pointed out that addressing such data gaps that are outside the initial concern under SEV and

subsequent draft decisions was problematic for them and one Member State proposed that

ECHA should at least support Member States by providing standard texts to address such

standard data gaps. ECHA accepted the proposal and pointed also to the new working group

that will collect best practices in drafting the decisions.

Concerning the SEV conclusion document, some Member States and the Commission were of

the opinion that all SEV conclusion documents should be presented and discussed at RIME

meetings as part of the RMO analysis when new RMOs are proposed, whilst others were of

the view that the SEV conclusion document is an outcome of the SEV process and only the

possibly related or subsequent RMO analysis is to be brought to RIME. ECHA proposed

further reflection before concluding on the need to discuss all conclusions and on the

appropriate place for such discussions but welcomed suggestions to be included in the

workshop report.

A Member State expressed concern on the expected work for the follow-up evaluation in

cases where the registrants have not submitted all requested information and enforcement is

foreseen. The Member State held the view that the drafting of the Statement of Non-

compliance (SONC) is a task for ECHA. ECHA explained that it might not have the

necessary technical expertise to take that task but would be available to support the Member

State CA in the drafting of SONC and the related documents.

Some Member States and the Commission expressed their wish to submit written comments

on the workshop conclusions and, although not explicitly requested on this occasion, ECHA

concluded that any possible written comments, as well as nominations to the new working

group on SEV decisions, should be submitted to ECHA by 15 August 2014.

6.4 Publication of substance evaluation report

The overwhelming majority of Member States expressed their support for ECHA's proposal to

extract from the current, comprehensive SEV report a more concise public report. One

Member State expressed its dissenting view but agreed to follow the majority view and

volunteered to continue participating in the working group to ensure that all essential elements

of the evaluation are still reflected in the published SEV report. Another Member State as

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well as several observers highlighted the importance of transparency and quality of the SEV

report which should not be reduced. The Member State also called for flexibility, given that

some Member States may have already established efficient practice in writing high quality,

comprehensive SEV reports.

ECHA concluded the discussion by explaining that the working group on SEV reports would

revise the template in accordance with the agreed line, with the aim of having the new

template by the end of 2014.

9.1 Endocrine disruptors REACH Review CA/64/2014 & CA/25/2014

The Commission presented the revised document, for which it had taken into account

comments submitted following the last meeting of CARACAL.

One Member State asked for the text to say that applicants have to provide reasonable proof

of threshold. On page 10, 3rd

paragraph, that Member State would prefer a softer wording than

‘demonstrate’ in the direction of: ‘to make it plausible’ or to add ‘to the satisfaction of RAC’.

Otherwise the Commission’s conclusion could be interpreted as too stringent. Two other

Member States agreed that the word "demonstrate" was too strict.

One Member State repeated its view as already mentioned in their written input that the

Commission had only done half of the job as the review obligation also included an

evaluation of whether the scope of Art. 60(3) should be expanded to cover endocrine

disruptors in general. Only the threshold issue has been evaluated so the other part of the

review had not been delivered. However, the Member State agreed with the conclusions of

what had been done.

One Member State welcomed the Commission's conclusion that it did not exclude by default

the existence of thresholds for EDs.

Another Member State was able to endorse the document and enquired about the next steps

that the Commission envisaged.

One Member State also endorsed the document. They informed that on 4 July their

government had started legal action against the Commission for not having established ED

criteria in December 2013 as required by the Plant Protection Products and the Biocidal

Products Regulations. Another Member State sympathised with the legal action taken. They

also asked for more information on what is going on with the roadmap, the development of

the criteria etc.

One observer expressed strong concerns that RAC continued to develop reference DNEL's for

EDs as already had been the case for DEHP. It should be up to the applicants to do this. RAC

should only decide if industry has sufficiently demonstrated a threshold and not if there is a

threshold.

Another observer had hoped for more changes in the document compared to the earlier

version and criticised that it did not mention at all or address the concern relating to e.g. the

raising cancer rates and the urgent need for reduction of exposure to EDs. They expected that

a lot of difficult discussions will come forward based on this paper They further asked if there

will be guidance on how to demonstrate a threshold and whether substances already classified

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as reprotoxic that have an endocrine mode of action would be identified as endocrine

disruptors. They inquired also in which committees or groups discussions on this topics would

take place.

The Commission explained that it had taken on board several comments from the Member

States. The wording with regard to thresholds in Article 60(3) of REACH is ‘to determine’ –

the Commission considered ‘to demonstrate’ to be rather close to that but indicated that it was

prepared to reflect on the suggestions for different wording made by the Member States. The

Commission disagreed with the assertion that it had only done ‘half a job’. With regard to the

next steps, the Commission informed that it intended to publish the review as a formal

Communication – as for other reviews mandated by REACH. The necessary internal

consultations would be launched soon and publication could then be expected by the end of

this year.

With regard to the ED criteria development, the Commission explained that the roadmap had

just been published. The roadmap provided for several options for defining the ED criteria

which will be examined in an impact assessment. In line with the standard rules for carrying

out Impact Assessments, a public consultation will be launched, containing a list of multiple

choice questions for the general public and also a part for experts and stakeholders. The

purpose is to collect information and data to inform the Impact Assessment. The Commission

encouraged broad participation and the submission of useful data. The Commission expected

to launch the public consultation in September. In parallel the Commission is preparing

contracts for projects on cost/benefits analysis, with the Joint Research Centre (JRC) being a

key actor in this. Due to the length of the process the final criteria will be ready at the earliest

by the end of next year.

One observer asked about the new ED strategy and the review of the existing strategy. The

Commission replied that the review of the existing strategy is expected to be released soon,

while it had been decided not to go forward with a new ED strategy – this will be left for

decision by the new Commission.

7.1 Commission position on REACH and Recycling - CA/68/2014

The Commission presented the paper on REACH and Recycling, which had been drafted as a

follow up to the two papers presented at the 12th

and 13th

CARACAL meetings, respectively.

The Commission considers that the only way for a recycled material to leave the waste regime

was by the application of specific EU end-of waste criteria or, alternatively, by a Member

States decision on a case by case basis that a specific waste has ceased to be waste taking into

account the applicable case law.

One Member State welcomed the paper but explained that it was too ambiguous to be really

useful to determine whether REACH applied or not to materials that operators claim have left

the waste stage. The Member State expressed frustration that the issue, though a reality for

operators and enforcers for many years, is still not resolved by the Commission paper and

requested that an integrated approach be taken by the Commission dealing with all open

REACH / waste issues, including the 20% rule on impurities in the Guidance on Waste and

Recovered Substances. The Member State expressed doubts about the last paragraph of the

paper as to whether an authorisation granted by the Commission for the use of substance

listed in Annex XIV that is present in a recovered material could add to the proof that it has

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left the waste stage. It seemed in contradiction with the rest of the paper stating that

compliance with REACH does not mean that a material left the waste status.

The Commission concurred that there was indeed deep frustration among all parties caused by

the lack of clarity on REACH and waste issues. The crucial point was that the obligation to

achieve End of Waste status via compliance with provisions on specific EU EoW criteria or

via decisions adopted at the national level, based on existing case law, seemed simply not to

be applied correctly in many Member States. As a result of this uncertain situation, operators

are often unable to prove their EoW status for becoming a "product" under REACH and often

act on the basis of their own assumptions without a specific formal legal backing to their

actions.

The Commission emphasised that the responsibility to give legal certainty to operators on

how to obtain end of waste status was shared between the Commission and the Member

States. However, the Commission is responsible for proposing harmonised EU End of Waste

criteria for certain waste streams (which for several waste streams had recently not been

supported by the Member States) and recalled that adoption of EU harmonised End of Waste

criteria was also the responsibility of Member States. In their absence, Member States are free

to give case-by-case EoW decisions for the materials they consider to qualify for such

recognition within their territories, taking into account the applicable case law.

As for the recognition in the Commission paper that the fact that a recycled material fulfils the

conditions to be authorised under REACH could be a sign that some of the conditions to cease

being waste are fulfilled, the Commission expressed that this does not automatically imply

that the material has ceased to be waste, but is one of the elements to be taken into account in

that assessment, and hence is fully coherent with the rest of the paper. However, it would be

unrealistic to defend the view that such potential authorisation would be meaningless when

exploring compliance with the conditions set by the ECJ case law on end of waste.

One Member State supported the Commission's paper and emphasised that it welcomed the

debate on End of Waste. Crucial to the discussion was the balance between the desire to

increase recycling activities and striving to eliminate toxic chemicals from products. The

Member State suggested making the paper available to the Technical Adaptation Committee

(TAC) under the Waste Framework Directive and asked the Commission about the envisaged

next steps. The Member State also asked about a section in the "Guidance on the

interpretation of key provisions of Directive 2008/98/EC" referring to "single case decision"

which did not seem to be in line with the Guidance on the Waste Framework Directive, and

enquired whether the non-notification of single case decisions is linked to the concept of ‘implicit

End of Waste status’ as referred to in the Commission’s note.

A Member State supported the need for a holistic, integrated approach on REACH/waste

issues, but considered the Commission's paper referring to the current situation as regards

end-of-waste as a "legal fiction" because it fails to recognise the real world.

One Member State expressed surprise that "implicit" end-of-waste recognition could not be

accepted and stressed that it would send the message to its national ministry that end of waste

needs to be confirmed officially with the consequence that many operators today actually

operate under the waste regime. The Member State was in favour of the idea of a joint session

on chemicals and waste to motivate the different services involved to find practical solutions.

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One Member State referred to the paper it had circulated on SVHCs in recovered materials. It

stressed that the Guidance on Waste and recovered substances was not clear whether recovery

of an individual substance is different from the recovery of a material that contains this

substance. It suggested an extension of the sunset date in Annex XIV for SVHCs in recycled

materials in consideration of the lifecycle duration for the products to be recovered, drawing

attention to the fact that in their Member State it is mostly micro-enterprises that are involved

in recycling. The Member State also requested clarification in the guidance with regards to

how to deal with SVHC impurities / components in recycled materials.

One Member State supported the Commission's paper and the view that the authorisation

decisions could be made independently of waste legislation. In their view authorisation

requirements should apply equally to virgin and to recovered materials.

Another Member State supported the paper and the frustration expressed by other participants,

and endorsed the idea of organising a joint meeting with waste colleagues.

One Member State expressed the difficulties they often encounter in interacting with the

colleagues in their administration responsible for waste, and supported the idea of a joint

meeting of REACH and waste authorities.

The need for a holistic approach was supported by another CA, who saw the need for a

European initiative on this, and not only actions at national level. Reconciling the aims of

increasing recycling levels and at the same time reducing the use of dangerous substances in

recycled materials is a huge challenge.

One Member State stressed that it still had concerns with the paper and joined other Member

States call on the need to work together with the waste colleagues.

One Member State indicated that there should be a common approach to waste and REACH

issues and that the definition of EoW status should be clear and preferably done at EU level.

One Member State wondered whether recycling is working well in other countries and

stressed that there was concern in their Member State.

One observer noted that recycling is at the heart of industrial policy and the circular economy.

The observer stressed that there needed to be convergence on work in REACH and in waste.

The Commission’s paper focussed only on small issues - also the fact that operators often

"shop for waste regimes" should be considered as it is a reality. Therefore they strongly

advocated a common approach, taking into account the need to lighten the burden for SMEs,

and supported a joint workshop as suggested by several Member States.

The Commission indicated its willingness to organise such a workshop on REACH and waste

interface issues, bringing together those responsible at EU and national levels for chemicals

and for waste in order to clarify the situation and to cooperate in order to providing a coherent

and transparent framework in which the flow of materials in a circular economy can take

place. The Commission also addressed industry's responsibility in successfully establishing

EU harmonised End of Waste criteria and said that industry's persistent efforts in setting End

of Waste criteria before the recovery operation stage (at the collection stage) and not after is

of no help at all for the REACH and waste interface. The Commission also committed to

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present a paper on the issue of SVHC being impurities in other materials and the 20% limit in

the context of authorisation for the next CARACAL meeting in November 2014.

8.1 REACH/ROHS and REACH/POP common understanding papers

CA/35/2014, CA/36/2014, CA/37/2014, CA/38/2014, CA/39/2014

The Commission briefly introduced the history of the two Common Understanding papers,

explaining that comments had been accepted long after the expiry of the deadline set at

CARACAL 13 (31 January 2014) and that full reactions to all comments were reflected in the

response to comments documents prepared for each paper. A few changes had been made to

the papers as a result of comments made. Now, CARACAL was asked to endorse both papers.

One Member State queried the deletion of a sentence stating that it was not yet clear whether

DecaBDE satisfies the criteria for a POP. In their view, since the paper was written it had

indeed become clear and so the sentence should be removed. At the request of another

Member State, it was agreed to add a sentence to the effect that the two papers would be

reviewed in the light of experience gained and changing circumstances. It was also agreed that

the REACH/POP paper should clarify that, in order for the EU to 'opt-out' of the POP

Convention, Member States must be consulted through the appropriate Council Working

Group as part of that process. Finally, one Member State asked a question in relation to the

REACH/RoHS paper about the effect of alterations to exemptions granted under the RoHS

Directive on the exclusion of EEE from REACH. As no other Member State shared these

concerns, it was agreed that the matter could be discussed and resolved bilaterally with the

Commission.

One observer requested CARACAL to endorse the papers.

The Commission concluded that the papers were endorsed and, once the agreed changes will

have been made to the papers, they will be uploaded onto the Commission services' website.

8.2 Cadmium in plastics – outcome of the review (CA/63/2014, CA/63/2014 Annex 1)

The Commission and ECHA introduced briefly the case and requested comments from

CARACAL on the documents prepared by ECHA.

Two Member States supported an evidence based approach and thus were of the view that

more information should be gathered before a restriction can be considered. Compliance

check or Substance Evaluation were regarded as possible solutions for this. This was also

supported by one observer.

One of these Member States pointed out that the cadmium pigments are not classified as

carcinogenic. It wanted to know if uncertainties in the registration dossiers relate to the

quality of the information or to the standard information requirements and noted that there are

several C&L notifications on cadmium pigments. It further wished to know whether the

notifiers had been contacted in order to collect data on actual uses of cadmium pigments,

since, if there are no uses, then a restriction proposal would be pointless.

ECHA replied that the registration dossiers of two cadmium pigments contain many data

waiving justifications and read-across to cadmium telluride. ECHA had doubts that the

14

standard information requirements are fulfilled, especially in relation to long term effects.

ECHA confirmed that C&L notifiers had not been contacted individually, but different plastic

associations, national associations and some companies had been contacted via a

questionnaire and directly by the consultant that supported ECHA. In addition, two calls for

evidence had been organised.

Two Member States wished to go ahead with the restriction with the current information

using ‘read-across’ to the current restriction on cadmium and its compounds in plastics and

that instead of ‘unacceptable risk’, it would be worthwhile to base such a restriction on the

concept of ‘unacceptable use’. One observer supported this view.

The Commission reminded CARACAL of the Court case concerning the extension of the

current restrictions that had been enacted earlier. The case had been lost, as the Court had

concluded that a risk assessment should have been done for the specific uses that had now

been examined by ECHA. Based on the data summarised in the report, ECHA had concluded

that it was not possible to demonstrate a risk, and the entry in the Registry of Intentions was

subsequently withdrawn. Therefore, it will currently not be possible to go ahead with a

restriction proposal.

ECHA noted that it had conducted a preliminary analysis of exposure to cadmium from the

pigments via the food chain to humans. Due to many uncertainties in the assessment it had

decided not to use this as a further basis for a restriction proposal.

One Member State expressed concern that this case gave the wrong signal to industry if no

regulatory action can be taken when registrants are not providing the requested information.

An observer stated that a general accusation of ‘industry' was not justified and noted that

pigment manufacturers had tried to provide information available to them, but the down-

stream users did not always react to inquiries. The same observer also stated that hazards had

already been evaluated under the C&L process. Currently, information on the release of

cadmium/pigments from the plastic matrix is scarce and could be further investigated.

ECHA reiterated the option for starting a harmonised classification and indicated that it would

be happy to convey its experience with the dossier to any interested Member States.

The Commission invited Member States and observers to provide comments on the

CARACAL papers by 31 August 2014.

CLP

10 IMPLEMENTATION OF THE 5TH

REVISION OF GHS

The Commission provided a short introduction on the remit of the discussion, which would

focus on the items that had been put to discussion in Document CA/55/2014.

(a) Changes to Annex VII

The meeting was consulted on whether the table providing the translation of classifications

under the old classification regime to CLP should be changed. Six Member States and two

15

observers shared the assessment of the Commission that Annex VII would not become

automatically obsolete with the revocation of the Dangerous Preparations and the Dangerous

Substances Directives in 2015, but that it would become obsolete over time due to new

available data. Some of those Member States considered that the Annex should be revoked in

a later revision of CLP. Some of those Member States and observers explained that the table

was still useful, for instance for enforcement authorities.

(b) Inclusion of figures illustrating the tiered approach in chapters 3.2 and 3.3 on skin

corrosion and eye damage

Three Member States and one observer supported the uptake, one of them supporting the

uptake without footnotes. Three Member States expressed the view that the figures would be

suitable for guidance. One Member State expressed the view that the decision would depend

on whether the figure was too imprecise and more geared towards testing strategy than

classification. This Member State reserved its position and announced comments in writing.

(c) Alignment of CLP to GHS regarding the classification as Category 1 (without sub-

categorisation) for the classification of mixtures where the additivity approach does not apply

Nine Member States supported the proposed option to align the CLP to GHS by changing

section 3.2.3.3.4.3. Two of those Member States underlined that this approach would ensure

better consistency with the efforts undertaken to develop a system of assigning the appropriate

transport conditions under the UN Transport of Dangerous Goods framework. Two Member

States explained their reasons for preferring this option: The sub-categorisation had been

introduced in the GHS with a view to the use of in-vivo-test data whereas more in-vitro-

assays are being used since. The sub-categorisation was not able to reflect the reality. Another

Member State took the view that it was already recognized that sub-categorization was not

possible where classification was based on extreme pH.

One Member State reserved its position on this item.

(d) Use of “ingredient “or “component “in Chapters 3.2 and 3.3 on skin corrosion/irritation

and serious eye damage/eye irritation

The question on whether the GHS terminology “ingredient” should be consistently taken over

in the chapters 3.2 and 3.3 of CLP was seen differently by Member States: Three Member

States and one observer supported alignment of CLP to GHS (one Member State underlining

the need to develop a definition of “ingredient” in CLP guidance). Two other Member States

requested consistent use with REACH, i.e. maintaining the use of “component”. One of these

Member States took the view that the term “ingredient” could also include mixtures as

ingredient.

(e) Revision of Annex VI modifying the entries including harmonised classification for skin

corrosion to include also classification for serious eye damage (in accordance with current

CLP 3.3.2.3)

Six Member States took the view that Annex VI should indeed be changed, to avoid

inconsistent self-classification in regard to eye damage and inconsistent information in Safety

Data Sheets. The view of the Commission that such a change should be the object of a

different ATP was supported.

16

(f) Rationalisation of the labelling in regard to additional hazard statements EUH 204, EUH

205 and EUH 208

One Member State took the view that the wording suggested in the draft annex was

appropriate. Another Member State underlined that the rationalisation was welcome and EUH

204 and 205 should follow the same logic. The rationalisation was supported by an industry

observer.

Another Member State took the view that both EUH 204 and 205 were examples of bad

regulation by not providing lower concentration limit values. The Commission explained that

the two preparatory sessions of the Sub-CARACAL for ATP had explored the reasons for the

absence of such lower concentration limit values. There are reasons to believe that

isocyanates were considered a special case, well known especially in an occupational safety

and health context as strong sensitisers. It therefore seemed appropriate to maintain the EUH

statements while establishing clear rules to avoid duplication with EUH 208.

11 LIQUID CONSUMER DETERGENT IN A SOLUBLE PACKAGING FOR SINGLE USE –

CA/58/2014

The Commission presented its three-step approach, including a first set of measures related to

the outer and inner packaging of the product to be incorporated under CLP Article 35(2) via

the urgency procedure. The Commission also intends to launch a study to measure the

effectiveness of the currently proposed measures and to assess in more detail the impact of

potential further measures.

An observer provided information about its commitment to expand the product stewardship

programme related to liquid laundry detergents in soluble packaging. It stressed that there is

no single root cause for accidents and that a package of risk mitigation measures, comprising

both legislative and voluntary measures. The observer clarified that it is working on

definitions for child-impeding closures, on “accidentology” and on the development of a

mechanical resistance test. It also showed an example of a voluntary consumer awareness

campaign. It stressed that industry is committed to ensuring the safe use of its products.

Fifteen Member States and two observers expressed their support for the Commission’s paper

and the three-step approach. Among those Member States and observers, the following

specific views were expressed.

One Member State questioned the effectiveness of some of the voluntary measures by

industry (in particular the quality of box closures/lids) and welcomed that further measures

(including a removal from the market) would be considered if the first sets of measures would

not prove effective. Another Member State stressed the clear increase in the number of

incidents according to a recent national poison centre study.

Two Member States questioned whether the measures would be necessary if the current

provisions are adequately enforced in Europe. One Member State expressed doubts whether

provisions for general rules of quality of packaging could be done through comitology

procedure. This Member State considered that this is not in the scope of the second or third

subparagraph of Article 35(2), which could subject to adaptations to technical progress (Art.

53). The Commission replied that an adaptation of Article 35(2) could be justified as the

proposed measures were in the same context as the current provisions of Article 35(2)

17

(packaging of dangerous chemicals and protecting children from their release). In addition,

the urgency of action in order to protect the health and safety of children in relation to new,

previously unknown dangers was a further argument in favour of comitology.

One Member State asked the Commission to phrase the measures in a more general manner.

One other Member State stated that measures in other legislation, such as REACH

restrictions, should also be considered. The Commission clarified that measures under other

legislation will be considered at a later stage, if warranted. One Member State pointed out

some minor inconsistencies in the proposed legal text; written comments will be provided.

Scope

With regard to the scope of the measure, six Member States preferred limiting the scope to

laundry detergents for the time being, in particular since there is no evidence that other single

use products have caused a problem. Seven Member States expressed a preference for

including liquid dishwashing products in the measure. Two Member States indicated that

there are other products with soluble packaging, such as floor cleaning products or pesticides,

which could also be considered. One Member State underlined the significant expansion of

the market given the introduction of new products in soluble packaging, notably dishwashing

capsules.

Child-impeding closures

Various Member States agreed with the proposal of requiring child-impeding closures. One

Member State questioned the enforceability of child-impeding closures in the absence of clear

standards. The Commission committed to providing more clarity in the next version of the

legislative proposal. One Member State agreed that additional requirements are needed

relative to what is on the market now, but child-resistant fastenings (CRF) should not be

required. One observer also stated that CRF is not appropriate for products in everyday use,

since the lid would most likely be left open for convenience. The Commission stressed that

the right balance needed to be found to allow daily use, including by elderly people and to

prevent small children to be able to open the boxes. The Commission called on cautiousness

when using arguments related to avoiding undesirable behaviour, such as leaving boxes open,

as they could be taken to be questioning the effectiveness of existing requirements in CLP.

Mechanical resistance and dissolution time

Regarding the minimum mechanical resistance, one Member State indicated that 600 N is not

realistic based on industry feedback, while another Member State clarified that it had received

industry feedback confirming the feasibility of the 600 N limit. One observer stated that the

600 N minimum is certainly not realistic, since this would require a much higher median

resistance. One other Member State favoured specifying the resistance of the soluble film in

potential measures. Regarding the minimum dissolution time, one Member State requested

this to be stipulated precisely, rather than relative to something else, for the purpose of

enforcement.

Other measures

18

Various Member State supported the requirement of an aversive agent. One Member State

indicated that the agent should be specified, while another stated that this should not be done

to avoid giving preference to one specific chemical.

One Member State questioned why the option of adding non-soluble wrapping around the

individual doses was not retained in the proposed package. The Commission cited the

significant additional costs for industry. Adding a new element in the production lines would

be difficult to implement in the short term. In addition, there would be a potential additional

risk when consumers attempt to open the individual wrapping unsafely (e.g. with scissors).

Two Member States and one observer favoured colour restrictions for the liquid detergents.

The Commission indicated that according to Italian and U.S. poison centre data no

statistically significant link could be confirmed between certain colour variants and the

number of accidents. In addition, it would be difficult to justify colour restrictions of the

liquid detergent under CLP, as they concern the product and not the packaging (and thus they

would rather be a matter for REACH). Nevertheless, the effectiveness of potential colour

restrictions will be assessed in the planned study.

One Member State enquired about the transition time for the measure and about whether

selling of stocks was still possible after 1 June 2015. Another Member State stated that new

requirements should be aligned with the 1 June 2015 CLP timeline. The Commission clarified

that the measures concerned placing on the market from 1 June 2015. Legal confirmation will

be sought whether this implies a transition time for the sale of existing stocks after 1 June

2015.

Other comments

One Member State indicated that detergent boxes are often used as toy containers afterwards.

One Member State indicated that its REACH/CLP authority in collaboration with national

detergents associations released press materials focused on safe use of these products.

12 QUALITY SYSTEM OR STANDARDS USED FOR PHYSICAL HAZARD TESTING REQUIRED BY

ART. 8(5) CLP – CA/40/2014

The Commission reiterated the issue discussed at the previous CARACAL meeting regarding

the new requirement under the CLP Regulation to perform physical hazard tests "at the latest

from 1 January 2014, in compliance with a relevant recognised quality system or by

laboratories complying with a relevant recognised standard". ECHA Guidance interprets this

requirement as compliance with GLP, application of ISO 17025, or "other internationally

recognised standards of comparable scope".

The Commission presented different options to address the lack of clarity in the guidance: (1)

leaving the ECHA CLP Guidance as it is, which does not exclude the interpretation that ISO

9001 is sufficient to fulfil the requirements of Art. 8(5) CLP; (2) specifying that standards on

general management systems, such as ISO 9001, are not sufficient, but leaving room for other

not further specified methods; (3) removing the option of "other internationally recognised

standards" entirely and replacing it by a positive list, which would currently mean that only

GLP and ISO 17025 are allowed, as no other comparable standards were so far identified.

Seven Member States voiced a preference for option 2, mostly indicating that a positive list of

standards would be difficult to establish. One Member State also expressed a preference for

19

option 2, but indicated that enforcement authorities prefer option 3, which leaves less room

for interpretation. Three Member States stated that option 3 would be the best option, since

there are no other recognized standards and physical hazard tests should be performed in

compliance with either GLP or ISO 17025. One of these Member States underlined that

unambiguous wording in the guidance is crucial. One Member State indicated that the

guidance should be improved and that the guidance wording should not be a duplication of the

Regulation. Various Member States reiterated that ISO 9001 is not sufficient for laboratories.

Two observers commented that simple physical-chemical tests (e.g. flash points) are usually

conducted by small companies that do operate a quality management system but do not have

the capacity to comply with GLP or ISO 17025. They added that a requirement for GLP or

ISO 17025 would make it impossible for such companies to conduct these tests themselves.

ECHA underlined that consistency with the BPR Guidance, which allows for the use of ISO

9001, is important and encouraged Member States to liaise with their BPR counterparts.

13 BIOELUTION / BIOACCESIBILITY TESTING (EUROMETAUX PRESENTATION) – CA/56/2014

Eurometaux presented its work on the development of bioaccessibility and bioelution testing

approaches. An internationally agreed test method is currently lacking. According to

Eurometaux, a significant amount of work has already been performed. Yet, the testing

approaches need to be made more robust, e.g. by standardizing protocols. For the adoption of

an internationally agreed test method at OECD level, an OECD member will need to submit a

project proposal to the OECD. Eurometaux encouraged CARACAL members to support these

efforts.

14 BURNS CAUSED BY DENATURED ALCOHOL – ADDITIONAL PACKAGING AND LABELLING

REQUIREMENTS AT MS LEVEL

The Italian CARACAL member provided information about a provisional measure on

denaturated alcohol, a mixture containing ethanol and additives. The misuse of this product

has led to numerous burn victims, including 14% pediatric burns. The Italian Ministry of

Health had issued a draft decree under the safeguard clause of CLP Article 52, requiring the

opening hole of the bottle to be equal to or greater than 6 mm in order to avoid the return of

the flame. The question is raised whether the safeguard clause under CLP is appropriate, or if

the safeguard clause of the REACH Regulation (Article 129, requiring the Member State to

initiate a REACH restriction procedure) or the Detergents Regulation (Article 15) should be

considered. Italy considered the latter option as denaturated alcohol is mostly used as a

detergent and can fall under the definition of a detergent in the Detergents Regulation.

One Member State cited the restriction under REACH for lamp oils as a similar example.

Another Member State considered CLP to be the most appropriate context for this measure.

In response to a question whether such a provision on the opening hole of bottles is covered

by the harmonised area, the Commission indicated that it is a borderline case. The

Commission invited Member States to report whether there are similar problems in other

countries and whether a measure on an EU level is needed.

20

Two Member States indicated that no similar incidents have been reported in their countries.

Data from institutions collecting data on burning incidents (rather than only poison centres)

should be taken into account.

Written feedback can be provided until 19 August 2014.

15 WORKSHOP ON SAFE USE OF CHEMICALS – MS REPRESENTATIVE REGISTRATION

CA/53/2014

The European Commission will organise a workshop on the safe use of chemicals on 16

September 2014. The objectives are to identify main challenges for a timely implementation

of the CLP Regulation, to discuss practical solutions to the specific needs of SMEs and to

promote the safe use of chemicals in Europe. One governmental expert per Member State can

be reimbursed. All participants are encouraged to register online:

http://ec.europa.eu/enterprise/sectors/chemicals/reach/events/index_en.htm#h2-1 All

registrants are advised to await the final confirmation of their participation from the

Commission before making travel arrangements.

16 CLP ARTICLE 33(2) LABELLING OF OUTER PACKAGING – CA/MS/66/2014

One Member State submitted a paper on the requirement in CLP Article 33(2) to label both

the inner and outer packaging in accordance with CLP in case the package is not required to

meet the labelling provisions for the transport of dangerous goods. According to this Member

State, a problem arises in implementing this provision when the outer packaging contains

several different products classified and labelled differently. ECHA Guidance recognises this

situation by stating that in such cases "the rules of Article 33(2) should be applied with care".

One Member State stated that the ECHA Guidance should be updated, including examples on

how to label such transport pellets containing multiple products. Three Member States

indicated that they would provide written comments.

This issue has also been addressed in a recent industry guidance document, which might not

be fully in line with the legislation, as it does not consider 'transport package' (as opposed to

'supply package') to be subject to CLP Article 33. One observer clarified the purpose of the

industry guidance document and questioned whether transport packages (consolidated for

onwards transport) should be considered as a package in the context of CLP. The observer

would look into the arguments, and -if necessary- would consider updating the document.

The Commission invited Member States to provide written comments.

17 ANY OTHER BUSINESS

One Member State enquired about the meeting organised by ECHA on biocides and CLP. At

this meeting, competent authorities for biocides were invited to discuss the alignment of CLH

and BP processes to increase efficiency and avoid duplication of work, in particular with

regard to the CLH report format. The Member State asked ECHA if a list of countries

working on substances could be made available. ECHA indicated that a registry of intentions

for CLH, including both biocides and pesticides, is already available. ECHA works with

EFSA, which is responsible for the pesticides list. ECHA acknowledged that the list is not

complete and encouraged Member States to notify any intentions related to biocides and

pesticides.

21

ECHA indicated that there was no decision yet whether a CLH dossier is required for

“obvious” cases, such as carbon dioxide and nitrogen. Furthermore, ECHA confirmed that in

case a CLH dossier is updated only the relevant endpoint(s) need to be addressed (rather than

a full dossier with all endpoints).