Tag: Chemicals

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Our scoping study on a principle of ‘essential use’ in international and European regulatory (particularly chemicals) law.

Update 1 March 2021 the paper has now been published  Transnational Environmental law – open acces.

Update 15 May 2020 see the ECHA consultation on PFAS regulation launched this very week.

With Kathleen Garnett I have co-authored a paper where we scope the ‘essential uses’ approach to product regulation, particularly in chemicals.

Could calls for the stricter regulation of one particular type of chemical herald the introduction of a new (or not) ‘principle’ in international and EU regulatory law, namely that of ‘essential use’ as a precondition for market authorisation?

The concept of ‘essential use’ or ‘non-essential use’ has been referenced in a number of EU policy papers. Kathleen and I focus on Per- and polyfluoroalkyl substances (‘PFAS’)  in chemicals legislation and firstly, map the concept of ‘essential use’ in international and EU law; further, discuss its limited application in the case-law of the European Court of Justice; and, before we conclude, carry out a preliminary investigation as to (if it does not currently exist in EU law), whether it might be so included de lege ferenda.

Happy reading. We are submitting to journal.

Geert, Kathleen.

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Is it me, or is it getting chilly? The EC and endocrine disruptors.

Do the newly negotiated EU rules on endocrine disruptors illustrate regulatory chill /the ‘freezing effect’ of international trade law?

The new European Commission proposals on endoctrine disruptors are, of course’ ‘science based’. It has been reported (EurActiv, 12 December 2016 and last consulted by me on 13 December) that publication of the proposals was followed by a closed door meeting (minutes of which were released only after a freedom of information request) between the EC and a select number of countries (US, Canada, Argentina, Brazil and Uruguay on 13 July this year). Discussion centered around the potential WTO incompatibility of parts of the EC proposal, particularly those surrounding the tolerance levels for endocrine disruptors present in imported substances (food and feed in particularly). The EC reportedly are prepared to replace “negligible exposure” with “negligible risk from exposure”. The EC defend the latter, arguing it might even ban more, rather than less imported substances: for even if there is only negligible exposure, that exposure may still be a risk. Opponents suggest that the insertion of a risk approach has sacrified precaution on the altar of science.

A few comments.

Firstly, the report (and potentially even the EC itself) repeats the misleading assertion that the debate concerns either science or precaution. Precaution is NOT unscientific. The very trigger of the precautionary approach is science.

Next, the case is reported at a time a lot of people are getting jittery about the regulatory co-operation mechanisms in free trade agreements such as CETA and TTIP. The meeting and the subsequent EC reaction to our trading partners’ comments, would then represent an example of the ‘freezing effect’ in international trade: with our trading partners flying the flag of WTO incompatibility, the EU would then have caved in to threats of litigation in Geneva. Yet in reality WTO input by fellow WTO Members is at least as old as the WTO itself, indeed it predates it. The 1978 Tokyo Standards Code already obliged the then GATT Contracting Parties to notify their draft standards to the GATT Secretariat. The very point of notification and transparency is that the issues raised are being discussed and may indeed lead to the draft standard being adopted. Changes made to REACH, to name but one example, reflected concerns of fellow WTO Members and REACH can hardly be said to pander to industry’s demands.

However there needs to be one core appreciation in this process: just as notification serves transparency (anyone can consult the TBT notification gateway to review draft measures that have been notified), so too should the process of review after reception of the comments, be conducted in a transparent manner. This clearly has not happened here. By conducting these meetings in private, and by refusing to release the minutes until prompted to do so, EC services have given the impression that there is more than meets the eye. In times where even CETA has not yet been ratified, that is most definitely the wrong approach.

Geert.

 

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Now Denmark joins the nano notification fray.

Denmark has adopted its regime for notification preparations and products containing nanomaterials. (Belgium ‘s regime as far as I am aware has still not been finally adopted – it is not the kind of measure which its care-taker government (coalition negotiations are underway) can justifiably adopt). The final text (Danish only) does differ from the text notified under the EU’s transparency regime, following comments by the EC and by other Member States.

The Danish text (which entered into force last Wednesday, 18 June) differs from the proposed Belgian regime: it targets consumer goods, not professional goods; it does not mutually recognise notification done in other Member States…The Belgian regime in turn differs from the French, and Norwegian (not an EU Member State but EFTA) scheme etc. Harmonisation at the European level is becoming ever more urgent: impact assessment at that level is underway and a proposal expected for the autumn. This will then presumably gazump any pre-existing national regimes.

Geert.

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Belgian nano-register inches forward

I reported earlier on the delay incurred by the Belgian nano register. Following objections under the EU’s transparency Directive, the Belgian register stood still. The Belgian Government is now tinkering with the proposal, having reportedly adopted a new draft which is being sent to various consultative bodies.

The new draft, a little bird tells me, adds additinal requirements in the light of occupation health and safety requirements; introduces 1 January 2016 as the deadline for registration of nanomaterials already on the market and 1 January 2017 for relevant mixtures; postpones until later the cut-off date for objects and complex preparations containing nanomaterials; and cancels the exemption for cosmetics containing nanomaterials.

Strangely, for a move designed to increase transparency, the new draft itself is kept under wraps for the time being.

Geert.

 

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REACH safeguard clause: EC allows first use by France and hints at flexible application

At the end of October, the European Commission authorised the first use, by a Member State, of the safeguard clause contained in the REACH Regulation. France has been allowed to ban cellulose wadding insulation materials used in buildings, to protect the public from exposure to ammonia released from ammonium salts in the materials. The authorisation will lapse in July 2015 lest an EU-wide ban on the substance, prepared  by France, will replace it by then.

As this was the first use of the measure, it remained to be seen how the EC would assess the French ban and the reasons for introducing it. It has adopted a great measure of deference to the national justifications invoked (in particular, incidents reported and initial measuring), even if the language of the safaguard itself is fairly restrictive.

Geert.

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Text of the safeguard clause (courtesy of REACHonline):

ARTICLE 129: Safeguard clause
1. Where a Member State has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance, on its own, in a preparation or in an article, even if satisfying the requirements of this Regulation, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based.
2. The Commission shall take a decision in accordance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State. This decision shall either:
(a) authorise the provisional measure for a time period defined in the decision; or
(b) require the Member State to revoke the provisional measure.
3. If, in the case of a decision as referred to in paragraph 2(a), the provisional measure taken by the Member State consists in a restriction on the placing on the market or use of a substance, the Member State concerned shall initiate a Community restrictions procedure by submitting to the Agency a dossier, in accordance with Annex XV, within three months of the date of the Commission decision.
4. In the case of a decision as referred to in paragraph 2(a), the Commission shall consider whether this Regulation needs to be adapted.

 

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EC, UK et al comments on Belgian nano-register delay its roll-out. No disguise of general unease vis-a-vis EC dithering.

The European Commission, the United Kingdom, The Czech Republic, Italy and Ireland have all issued detailed comments on the ‘nano register’ notified by Belgium.

Belgium itself had summarised the draft as follows:

The draft legislation implements a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market. 
To this end, the draft legislation mandates that substances manufactured at the nanoscale, and preparations containing them, be declared if more than 100 grams of these substances are placed on the market per year (the declaration covers the characteristics of the substances, the quantity of substances manufactured at the nanoscale placed on the market, the use of the preparation or substance concerned and the identity of professional purchasers and users). 
The draft legislation also lays down an obligation to make a simplified declaration for articles incorporating a substance or substances manufactured at the nanoscale, as long as more than 100 grams are placed on the market per year and the article emits more than 0.1% of substances manufactured at the nanoscale when in use (only a reduced list is required of the characteristics of the substances manufactured at the nanoscale). 
Provisions are laid down concerning data protection and confidentiality, as well as concerning research and development activities. 
The draft additionally covers the mutual recognition of the numbers of any declarations made by non-Member States, thus reducing the impact of the draft legislation on the free movement of the products concerned.

Under the notification procedure of Directive 98/34, Member States have to notify draft ‘technical regulations’ which may impede the Internal Market. This is followed by a standstill period and by an opportunity for other Member States, and the European Commission, to issue comments. Detailed comments extend the standstill period – in the case of Belgium’s nano register, now until early January 2014.

I am not in fact entirely convinced that the nano register is a ‘technical regulation’ under the Directive – Belgium would seem to have opted for the cautious approach, apparently in contrast with its approach vis-a-vis the mirror provisions under WTO law: the WTO has a similar regime under the Agreement on Technical Barriers to Trade (see also Agapi Patsa and Anna Gergely on same) – albeit with less strict consequences if a Member fails to notify. I was not able to locate Belgium’s notification in the TBT’s IMS  This database can be a bit moody, whence Belgium may have notified but I cannot find it. Alternatively, Belgium may have decided that the register does not qualify as a technical regulation under WTO law..

I have not been able (nor have I chased – perhaps some readers have) to get my hands on the comments issued by a handful of Member States and by the EC. . They are likely of course to relate to the impact on nano roll-out of a registration duty in a core Member State.

It is not unlikely that the Belgian initiative is meant in part to put pressure on the EC to beef up its own notification requirements. However the EC is dragging its feet on reporting on the public consultation re REACH and nano, and other Member States, notably Germany, which is pondering a separate notification proposal, are getting impatient, too.

Geert.

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Even hazardous wastes can be returned as products after recovery – Kokott AG in Lapin elinkeino. REACH comes to the rescue of Waste.

Kokott AG opined end of December in Lapin elinkeino, Case C-358/11 (at the time of writing this post, the English version of the Opinion was not yet available however plenty of other language versions are). I have included the referred questions below. The case involves the use, in accordance with Finnish law, of wood, formerly in use as telephone posts, as underlay and duckboards for a hiking trail in a nature reserve.For that purpose, it is CCA-treated (chromated copper arsenic: a mixture of chromium, copper and arsenic).

The REACH Regulation exempts waste: ‘To ensure workability and to maintain the incentives for waste recycling and recovery,
wastes should not be regarded as substances, preparations or articles within the meaning of this Regulation.’ At the time of adoption of the Regulation, this  led to the rather interesting development of clients seeking arguments to have their products considered waste (until then not a preferred option), for compliance under the Waste regulations was /is perceived as less onerous than REACH.

The Waste framework Directive, in the revised 2008 version, includes a specific regime in Article 6 for end-of-waste criteria. It is worth citing it here in full:

1. Certain specified waste shall cease to be waste within the meaning of point (1) of Article 3 when it has undergone a recovery, including recycling, operation and complies with specific criteria to be developed in accordance with the following conditions:

(a) the substance or object is commonly used for specific purposes;

(b) a market or demand exists for such a substance or object;

(c) the substance or object fulfils the technical requirements for the specific purposes and meets the existing legislation and standards applicable to products; and

(d) the use of the substance or object will not lead to overall adverse environmental or human health impacts.

The criteria shall include limit values for pollutants where necessary and shall take into account any possible adverse environmental effects of the substance or object.

2. The measures designed to amend non-essential elements of this Directive by supplementing it relating to the adoption of the criteria set out in paragraph 1 and specifying the type of waste to which such criteria shall apply shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 39(2). End-of-waste specific criteria should be considered, among others, at least for aggregates, paper, glass, metal, tyres and textiles.

3. Waste which ceases to be waste in accordance with paragraphs 1 and 2, shall also cease to be waste for the purpose of the recovery and recycling targets set out in Directives 94/62/EC, 2000/53/EC, 2002/96/EC and 2006/66/EC and other relevant Community legislation when the recycling or recovery requirements of that legislation are satisfied.

4. Where criteria have not been set at Community level under the procedure set out in paragraphs 1 and 2, Member States may decide case by case whether certain waste has ceased to be waste taking into account the applicable case law. They shall notify the Commission of such decisions in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services [24] where so required by that Directive.

Intriguingly, Article 6(4) [Member States deciding end-of-waste status on a case-by-case basis in the absence of Union harmonisation], does not refer to the four criteria which Article 6(1) puts forward as binding in the event of Union harmonisation on same. In contrast with the Commission, the AG suggests that this difference has to be taken at face value. The only benchmark for the Member States is the case-law of the ECJ on the end-of-waste status and on the very definition of waste. Once a Member States decides on that basis that even dangerous waste no longer is waste (or indeed never was waste), it can allow the use of such substance under application of relevant product legislation (here: the rules on CCA-treated wood under REACH).

Importantly, therefore, the AG suggests that dangerous waste can be returned to use as products, in the case at issue under discipline of REACH, in accordance with national law. Member States need not wait for Union criteria to be developed. As suggested therefore in excellent analysis by maitre Enckell, REACH comes to the rescue of the Member States wishing to encourage the return of even hazardous wastes to product status (lest of course the ECJ will see this differently). In the alternative, product use explicitly allowed under REACH for virgin material, would not so be allowed for recovered material. That would not be very sustainable.

Geert.

Questions referred

Questions referred
1    Is it possible to deduce directly from the fact that waste is classified as dangerous waste that the use of such a substance or object leads to overall adverse environmental or human health impacts within the meaning of Article 6(1)(d) of Waste Directive 2008/98/EC? May hazardous waste also cease to be waste if it fulfils the requirements laid down in Article 6(1) of Waste Directive 2008/98/EC?
2.    In interpreting the concept of waste and, in particular, assessing the obligation to dispose of a substance or an object, is it relevant that the re-use of the object which is the subject of the assessment is authorised under certain conditions by Annex XVII as referred to in Article 67 of the REACH Regulation? If that is the case, what weight is to be given to that fact?
3.    Has Article 67 of the REACH Regulation harmonised the requirements concerning the manufacture, placing on the market or use within the meaning of Article 128(2) of that regulation so that the use of the preparations or objects mentioned in Annex XVII cannot be prevented by national rules on environmental protection unless those restrictions have been published in the inventory compiled by the Commission, as provided for in Article 67(3) of the REACH Regulation?
4.    Is the list in Point 19(4)(b) in Annex XVII to the REACH Regulation of the uses of CCA-treated wood to be interpreted as meaning that that inventory exhaustively lists all the possible uses?
5.    Can the use of the wood at issue as underlay and duckboards for a hiking trail be treated in the same way as the uses listed in the inventory referred to in question 4 above, so that the use in question may be permitted on the basis of Point 19(4)(b) of Annex XVII to the REACH Regulation if the other conditions are met?
6.    Which factors are to be taken into account in order to assess whether repeated skin contact within the meaning of Point 19(4)(d) of Annex XVII to the REACH Regulation is possible?
7.    Does the word ‘possible’ in the point mentioned in question 6 above mean that repeated skin contact is theoretically possible or that repeated skin contact is actually possible to some extent?
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Size does matter. The European Chemicals Agency bans those who wrongly declare themselves small.

Under the European Union’s regime on chemicals (REACH), companies manufacturing or importing chemical substances have to notify considerable amounts of data to the European Chemicals Agency (ECHA). Under the general ‘no data, no market’ rule, those chemicals for which no appropriate risk assessment and risk management has been carried out, cannot be put on the market. What may seem a futile part of compliance – paying the correct registration fee – has now come back to haunt several companies.

ECHA’s machinery needs to be financed. Companies registering substances under REACH to that end pay a registration fee. Micro or small and medium sized enterprises (SMEs) receive a discount. Those incorrectly classifying themselves as small, have now had their comeuppance: ECHA has rejected their registrations, effectively meaning that the companies involved can no longer manufacture or import the substance above one ton per annum.

Lessons are clear. Firstly, one should always be careful with statements of size. Secondly, ECHA bites. It is one of only a few of the European Union’s Agencies which is truly ‘regulatory’ (also on issues of chemicals policy much more relevant than size).

Geert.