Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Consumer, Environmental and Health Technologies
Chemicals
Directorate-General for Environment
Green Economy
Chemicals
Brussels, 17 February 2016
Doc. CA/05/2015
20th Meeting of Competent Authorities for REACH and CLP (CARACAL)
8 - 9 March 2016
Room MANS, CHARLEMAGNE building
Brussels
Concerns: CASG-LP update on labelling and packaging issues
Agenda Point: 12.7
Action Requested: For discussion and comments by 8 April 2016
1. Progress
The following table lists the progress on each of the topics covered by the CARACAL sub-group on labelling and packaging issues (CASG-LP):
# / Topic / Progress1. / Multi-lingual fold-out labels / See below
2. / TDG-CLP interplay; interpretation of Article 33 CLP / Expert discussion took place in February 2016; experts are developing a proposal to be presented at CARACAL-21
3. / Use of chemical names / double labelling / Included in ECHA guidance update
4. / Goods without packaging & re-fill sales / See below
5. / Labelling of a two-component product / Included in ECHA guidance update
6. / Interpretation of P501 / Discussed at UN SCE GHS
7. / Font size / See below
Further information is provided on goods without packaging (Section 2), fold-out labels (Section 3) and font size (Section 4) below.
2. Goods without packaging and re-fill sales
At the first meeting of the CARACAL sub-group on labelling & packaging (CASG-LP), Sweden raised the issue of hazard communication of goods without packaging (such as fuels), which was previously regulated by national legislation under the Dangerous Substances/Preparations Directives (DSD/DPD).
As reported in CA/51/2015 and CA/89/2015, the Commission has organised several conference calls with experts in 2015 to discuss the need to regulate such goods without packaging and whether changes to the CLP Regulation would be needed. The minutes of the last conference call are included in Annex I.
According to recital 49 of CLP, unpackaged goods can be supplied to the general public "in exceptional circumstances". This is governed by Article 29(3), which stipulates that "when a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging it shall be accompanied by a copy of the label elements". Currently, the only entry in Part 5 of Annex II is ready mixed cement/concrete. Based on these provisions, there was agreement among the experts that CLP currently does not allow the sale of goods without packaging, except for ready mixed cement/concrete. Nevertheless, it was agreed that a pragmatic solution should be sought for fuel/petrol.
The Commission considers re-fill sales as a separate discussion, as described below.
2.1. Fuel
For fuel, there was agreement that the placement on the market occurs at the moment of filling the fuel tank/receptacle/package. Therefore, CLP labelling requirements do not apply to the fuel pump itself, but to the fuel. In this context, the fuel can indeed be considered as unpackaged. This means that this would require an inclusion of fuel in Annex II, which was proposed by various experts in the discussion group.
If included in Part 5 of Annex II, a copy of the label elements would need to be provided to the general public at the point of sale. The ECHA Guidance on labelling and packaging in accordance with the CLP Regulation (p. 3) gives the example of including the CLP label elements on the invoice. Within the group of experts, it was recognised that many fuel stations are unmanned and that it would therefore be sufficient to make a sticker with the correct label elements available at the fuel pump. It would be left to the consumer to take/use the sticker.
COM suggested considering the following option: Add fuel to Annex II and indicate in guidance that the Article 29(3) requirement can be met by making available a separate sticker or piece of paper with labelling information at the petrol station. It would be left to the consumer whether he/she would take the sticker. Therefore, self-service petrol stations would not be required to verify that every customer uses the sticker on their receptacle/jerrycan, but they would be required to at least make the sticker available.
The discussion group agreed that any potential new requirements should be very well justified and that it should first be confirmed that there is indeed a concrete problem (e.g. divergent approaches to the application of CLP requirements to fuel stations across Member States). Consultation with selected poison centres confirmed that there have indeed been some incidents with fuel, although the overall incidence and severity is unknown.
Therefore, the Commission invites CARACAL members to:
· Indicate whether the sale of fuel not being covered by Article 29(3) is indeed considered as a practical problem that warrants measures (supporting data from national poison centres could be relevant, if available).
· Provide comments on the proposal to add fuel/petrol to Part 5 of Annex 2 and to clarify in guidance that the Article 29(3) can be met by making a sticker with the correct label elements available at the fuel pump.
2.2. Re-fill sales of detergents
The Commission recognises the phenomenon of 're-fill sales', involving consumers bringing an empty receptacle to the store and re-filling it with a product, e.g. a detergent mixture. This reduces the use of packaging. The Commission generally applauds new ways of presenting products in order to reduce waste and contribute to the circular economy, but also considers it important that products are correctly labelled and packaged to ensure the safe use of chemicals.
Based on discussions in the Detergents Working Group, the Commission recognises that there are different types of re-fill sales. Whether or not such re-fill sales are compliant with the CLP Regulation depends on whether the customer leaves the store with a correctly labelled and packaged product. As the customer holds a fully labelled and packaged product when leaving the point of purchase, it is not considered as a good without packaging.
The store can ensure compliance in different ways. Some stores are known to have re-fill distribution machines that recognise specific receptacles (with the correct label) and only allow the re-fill if the correct receptacle is used; other stores consistently verify at the check-out whether the correct label is applied to the receptacle. Regardless of the method, CLP requires that the consumer leaves the point of purchase with a package that is labelled and packaged in full accordance with CLP. Member States are encouraged to enforce this strictly to avoid any poisoning incidents due to the absence of correct labelling and packaging.
3. Scope of fold-out labels
The work on fold-out labels has included two actions: (1) the development of guidance on the quality and design of fold-out labels and (2) discussions on extending the scope of fold-out labels.
With regard to guidance, wording on the durability and readability of fold-out labels and the accessibility of information on fold-out labels has been included in the on-going revision of the ECHA Guidance on labelling and packaging in accordance with the CLP Regulation.
The scope of fold-out labels was discussed at the CARACAL-19 meeting, based on three policy options:
· Option 1: Keeping the scope of fold-out labels unchanged
· Option 2: Allowing Member States to determine in which cases fold-out labels are permitted
· Option 3: Allowing the broader use of fold-out labels, provided that they comply with the strict quality and readability instructions to be outlined in guidance
Eight Member States and five observers were in favour of extending the scope of fold-out labels, although some with certain restrictions (e.g. maximum number of languages). Six Member States and one EFTA member were opposed to the extension of the scope. Various Member States explicitly considered option 2 to be the least preferable option due to the potential divergence of requirements across Member States. All written comments are shown in Annex II.
Although a plurality of Member States was in favour of the extension of fold-out labels, some indicated that certain restrictions should be considered. Various Member States also stressed the importance of adequate quality and readability of fold-out labels.
Based on these comments, the Commission proposes to amend the wording in Article 29(1) to allow for a broader scope for the use of fold-out labels, while including certain related quality requirements either in Annex II of CLP or in ECHA guidance. The Commission invites CARACAL members to comment on the requirements or restrictions that should be considered in any potential extension of the scope of fold-out labels.
Possible restrictions that could be considered are the following:
· Maximum number of languages
· Maximum number of pages
· Readability requirements on top of those in the current ECHA guidance revision
· Limitations in the format (e.g. book style, order-book style, window style, accordion style)
4. Font size
At CARACAL-19, the Commission presented the wording that was proposed to be included in ECHA guidance concerning the readability of fold-out labels:
Readability is determined by the combination of font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.
In addition to this guidance on fold-out labels, the Commission enquired whether a minimum font size should be considered for all labels.
The written comments received after CARACAL-19 are shown in Annex III. Comments are mixed: some CARACAL members and observers consider the readability of a label to be determined by various factors and do not favour prescribing a minimum font size in CLP, while others consider a minimum font size (e.g. as used under food legislation) to be warranted. The Commission will consider a follow-up in due course.
Annex I: Phone conference CASG-LP discussion group 4: goods without packaging
Attendees: Johanna Löfbom (SE), Hanna Korhonen (FI), Francis McGuigan, Jan Harris (UK), Caroline Bertein (A.I.S.E.), Fabienne van Raemdonck (COM-DG ENV), Maurits-Jan Prinz, Roberto Scazzola (COM-DG GROW).
Premise:
In the case of fuel, it was suggested that 'placing on the market' occurs at the moment of filling the receptacle/tank/package (rather than the mere presence of a fuel pump). It is not the fuel pump that is supplied but rather the fuel (without packaging). Therefore, CLP does not apply to the labelling of the fuel pump itself. Moreover, according to some, fuel pumps are already labelled in accordance with national requirements, e.g. in the framework of Directive 92/58/EEC on health & safety signs. Nevertheless, it should be noted that the parallel discussion on 'placing on the market' is still on-going and the application of this definition to goods without packaging remains to be considered.
There was agreement that CLP currently does not allow the sale of goods without packaging, except for ready mixed cement/concrete, as listed in Annex II, Part 5.
Fuel:
· There was agreement that a pragmatic solution is needed.
· In their written comments, SE/FI had indicated a preference to add fuel (placed into operational equipment) to the list in Annex II and to require labelling information to be made available through a sticker on the pump (without requiring a separate sticker or special container). However, COM indicated that Annex II, Part 5, is subject to Article 29(3), which requires the product to be "accompanied by a copy of the label elements", and questioned whether a sticker on the pump would meet this requirement. ECHA guidance gives a separate invoice with labelling information as an example to meet this requirement.
· COM suggested considering the following option: Add fuel to Annex II and indicate in guidance that the Article 29(3) requirement can be met by making available a separate sticker or piece of paper with labelling information at the petrol station. It would be left to the consumer whether he/she would take the sticker. Therefore, self-service petrol stations would not be required to verify that every customer uses the sticker on their receptacle/jerrycan, but they would be required to at least make the sticker available.
· All participants agreed that this could be a suitable compromise solution, but indicated that further internal discussion is needed. UK indicated that there may be national legislation on the labelling of petrol storage containers and will enquire internally. UK also underlined that any potential new requirements should be very well justified. COM agreed that it should be verified if this is indeed a problem, for which this potential solution can be justified.
Other products, such as detergents:
· FI indicated a preference to implement a solution for fuel only and questioned whether the sales of consumer products such as detergents should be allowed. SE also questioned whether the sales of consumer products such as household detergents should be allowed due to safety reasons.
· There was a discussion whether the above-mentioned proposal may also be suitable for other products, which could also be listed in Annex II. In such a case, a sticker or paper with labelling information should also be made available for such products. In any case, COM indicated that the sale of other goods without packaging should not be rejected ab initio. Further discussion will take place in the Detergents Working Group.
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Annex II: Written comments following CARACAL-19 concerning the scope of fold-out labels
MS / Option / Comments /CY / Option 1 / CY agrees with the opinion that the use of a fold-out label solely for the purpose of adding further non-required languages should not be allowed (option 1). Although this may seem too restrictive, we believe that the decision of a supplier to add more languages on a label, than those required in the Member State where the substance or mixture is placed on the market, would result to an unreadable and low quality label (small fonts, too much information, label not firmly attached on the packaging) and possibly too confusing for the consumer /worker.
We are of the opinion that in such cases the use of additional languages should be avoided and a separate label has to be prepared by the supplier using only the languages required in the MS.
DE / Option 3 / The German CA would support option 3 provided in document CA/89/2015 which allows under certain restrictions a wider application of foldout labels. Concerning labelling the key requirement is to provide the hazard information in a well-structured and easily accessible manner. Therefore a broader application of fold-out labels depends on a high quality of the label. Respective requirements are currently proposed for the UN GHS and the ECHA