Tag: REACH

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Tanchev AG in Esso supports broad application of animal welfare to REACH chemicals registration process.

In Case C‑471/18 P in which Tanchev AG Opined last month, Germany is asking the CJEU to set aside judgment in  T‑283/15 Esso Raffinage v ECHA by which the General Court annulled entitled a European Chemical Agency (‘ECHA’)  letter entitled ‘Statement of Non-Compliance following a Dossier Evaluation Decision under  [REACH]’. The letter concerned the outcome of ECHA’s compliance check of Esso Raffinage’s registration dossier for a particular chemical substance. The main thrust of its appeal is that the REACH Regulation does not provide for further examination by ECHA of the conformity of the information submitted with the first compliance check decision, and that this matter falls within the competences of the Member States pursuant to the REACH enforcement provisions. In support of its position, it argues that a registrant must conduct animal testing specified in the Evaluation Decision, and cannot submit adaptations at that stage.

Esso and ECHA find themselves in an unusual alliance with animal rights activists who argue that a registrant must be able to submit adaptations in lieu of performing animal testing specified in a first compliance check decision.

The case mostly concerns the respective competences of Member States and ECHA under Reach, I highlight it here for the AG’s emphasis on the relevance of animal welfare in the Regulation: consideration of animal welfare through the reduction of animal testing is one of the objectives pursued by the REACH Regulation. At 158: ‘Viewed more broadly, as indicated by Esso Raffinage and [NGO], the promotion of animal welfare and alternative methods to animal testing in the REACH Regulation reflects Article 13 TFEU, pursuant to which, in formulating and implementing the European Union’s policies, the European Union and the Member States are to pay full regard to the welfare requirements of animals.’

Animal welfare has come a long way since Michael Rose and I submitted it in CJEU C-1/96 Compassion in World Farming.

Geert.

 

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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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TPS-NOLO (Geobal): CJEU on take-back of ‘waste’, relation with REACH.

As I discussed with Stephen Gardner in Bloomberg Environment, the CJEU held yesterday in C-399/17 EC v Czech Republic, where the question is whether the Czech Republic has infringed the waste shipments Regulation 1013/2006 by refusing to take back a substance known as TPS-NOLO (or Geobal) that had been shipped to Poland without respecting the requisite formalities of the Waste Shipment Regulation.

Approximately 20 000 tonnes of TPS-NOLO (Geobal) and composed of tar acid, a remnant after refining oil (code 05 01 07* of the European waste catalogue), of carbon dust and of calcium oxide. Poland considered the substance to be hazardous waste classified in Annex IV to the Waste Shipment Regulation (‘Waste tarry residues (excluding asphalt cements) arising from refining, distillation and any pyrolitic treatment of organic materials’).  The Czech citizen responsible for the shipment to Poland presented the standards adopted by the company as well as proof that the substance in question was registered under the REACH Regulation and that it was used as fuel.

Wahl AG had suggested inadmissability, as I discuss here. The Court however disagreed, and on substance dismissed the EC action in five steps summarised very well in its case-summary. Of note in particular with respect to the REACH /WFD relation is that the Court holds that while the EC is right in being sceptical about WFD evasion via REACH (not that straightforward an assumption, given the cumbersome implications of REACH compliance), the Commission needs to bring specific evidence to the table rather than mere speculation.

Not an earth-shattering case yet a relevant one also with a view to circular economy debates, where REACH’ data requirements are an important concern for recyclers.

Geert.

Handbook of EU Waste law, 2nd ed. 2015, OUP, i.a.at para 1.201.

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Wahl AG proposes inadmissability in TPS-NOLO (Geobal): Take-back of ‘waste’, relation with REACH.

Another interesting waste-case at the CJEU last week, although unfortunately one in which Wahl AG proposes inadmissibility. In C-399/17 EC v Czech Republic, the question is whether the Czech Republic has infringed the waste shipments Regulation 1013/2006 by refusing to take back a substance known as TPS-NOLO (or Geobal) that had been shipped to Poland without respecting the requisite formalities of the Waste Shipment Regulation.

Approximately 20 000 tonnes of TPS-NOLO (Geobal) and composed of tar acid, a remnant after refining oil (code 05 01 07* of the European waste catalogue), of carbon dust and of calcium oxide. Poland considered the substance to be hazardous waste classified in Annex IV to the Waste Shipment Regulation (‘Waste tarry residues (excluding asphalt cements) arising from refining, distillation and any pyrolitic treatment of organic materials’).  The Czech citizen responsible for the shipment to Poland presented the standards adopted by the company as well as proof that the substance in question was registered under the REACH Regulation and that it was used as fuel.

The case raises interesting issues therefore on the relationship between REACH and Waste, on which I have written briefly inter alia here and, more extensively and with Dr Thomas de Romph, here. At 3 already, Wahl signals that his Opinion will not however lead to findings on the merits of the case: ‘ Finding that there was no infringement in the present case could potentially weaken the effectiveness and enforceability of the Waste Shipment Regulation, whose main and predominant object and component is protection of the environment. However, courts are guided, first and foremost, by procedural principles that ensure a due process in each individual case. Those principles cannot be sacrificed in order to further a greater cause, as noble as it might be.’

The due process issues essentially relate to the European Commission’s handling of the infringement procedure, in which, the AG suggests proprio motu,  it did not formulate a proper statement of claim. Details are in the Opinion and readers are best referred to it.

Now, there is no such thing as double jeopardy when it comes to infringement proceedings hence one can only hope that the Commission services will reinitiate the proceedings (lest of course the CJEU disagree with the AG’s Opinion).

Geert.

Handbook of EU Waste law, 2nd ed. 2015, OUP, i.a.at para 1.201.

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Cheers to that! The CJEU on excise duties, alcohol, packaging and regulatory autonomy in Valev Visnapuu.

Postscript 10 December 2015 For a similar exercise, see Sharpston AG in C-472/14 Canadian Oil.

Less is sometimes more so I shall not attempt to summarise all issues in Case C-198/14 Valev Visnapuu. The case makes for sometimes condensed reading however it perfectly illustrates the way to go about dealing with obstacles to trade put in place for environmental, public health or, as in this case, both reasons.

Mr Visnapuu essentially forum shops Estonia’s lower prices on alcohol by offering Finnish clients home delivery of alcoholic beverages purchased there. No declaration of import is made to Finish customs and excise, thereby circumventing (accusation of course is that this is illegal) a variety of excise duties imposed for public health and environmental reasons, as well as a number of requirements relating to retail licenses and container requirements (essentially a deposit-return system) for beverages.

Confronted with a demand to settle various tax debts, as well as with a suspended prison sentence, Mr Visnapuu turns to EU law as his defence in a criminal proceeding. The CJEU then had to settle a variety of classic trade and environment /public health questions: whether the packaging and packaging waste Directive is exhaustive on the issue of deposit-return system (answer: no and hence the system additionally needs to be assessed vis-a-vis EU primary law: Article 34 ff TFEU or Article 110 TFEU); whether in the context of that Directive excise duties on packaging may be imposed (yes) and packaging integrated into a functioning return system exempt (yes; in the absence of indications that imported systems are less likely to enjoy the exemption); whether the relevant excise duties fall under Article 34 ff TFEU or Article 110 TFEU (answer: it is part of an internal system of taxation hence needs to be judged vis-a-vis Article 110 TFEU); and finally whether the retail licence requirement needs to be judged viz Article 34 or Article 37 TFEU (answer: mixed, given the various requirements at stake). Final judgment on proportionality is down to the Finnish courts.

Readers in need of a tipple would be advised to postpone until after reading the judgment. Again though the case shows that if one keeps a clear head, classic structures of applying EU law go a long way in untangling even complex matters of law and fact.

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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Listing by ECHA of a substance as a candidate ‘substance of very high concern’ may be challenged in Luxembourg – The ECJ in Bilbaína de Alquitranes

In Bilbaína de Alquitranes, the ECJ (General Court) has held that producers of chemical substances may challenge the legality of the decision by ECHA to put a substance on the candidate list of ‘substances of very high concern’ under the REACH Regulation. The judgment is a useful addition to the strict conditions under the Treaty on European Union to seek judicial review of decisions made by the EU Institutions.

The appeal was rejected on substance, however both with respect to the issue of what are ‘final’ decisions that may be challenged, and on ‘individual’ and ‘direct’ concern, the judgment is worth a read. I have a summary of the issues pre-Lisbon over at SSRN. Especially in environmental matters, the Court’s case-law on locus standi has for a long time been very limiting.

Geert.

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