More Technical Notices (UK Brexit Preparedness)

The UK has today issued further Brexit Preparedness Notices. The existing online location is updated – here.

Please note particularly :

(1) CE marking – in the “Labelling products and making them safe” group

(2) Driving

(3) BAT standards – in the “Protecting the environment” group

(4) F-gases and ODS – in the “Protecting the environment” group

(5) The three Notices in the “Travelling between the UK and the EU” group

(6) Oil and gas activities – in the “Regulating energy” group

(7) European Works Councils in the “Workplace rights” group (already issued)

Any questions, please email me.

Indicative Occupational Exposure Limits (EU)

Directive 2017/164/EU – indicative occupational exposure limit values of 31 January 2017 establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directives 91/322/EEC, 2000/39/EC and 2009/161/EU (Text with EEA relevance) – is in force.

The Cardinal Environment EHS Legislation Registers and Law Checklists have the third list of indicative occupational exposure limit values. The fourth list is being added shortly.

The fourth list is based on Council Directive 98/24/EC concerning the protection of the health and safety of workers from the risks related to chemical agents in the workplace. This was the case for previous indicative lists.

Indicative occupational exposure limit values (IOELV) are health-based, non-binding values, derived from the most recent scientific data available and taking into account the availability of reliable measurement techniques.

For any chemical agent for which an IOELV has been set at European Union level, Member States are required to establish a national occupational exposure limit value. They also are required to take into account the European Union limit value, determining the nature of the national limit value in accordance with national legislation and practice.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 August 2018 at the latest.

Regarding the limit values for nitrogen monoxide, nitrogen dioxide and carbon monoxide, Member States will be able to benefit from a transitional period ending at the latest on 21 August 2023.

The 2017 Directive establishes limit values for the following chemical agents:

Manganese and inorganic manganese compounds (as manganese)

Glycerol trinitrate

Carbon tetrachloride; Tetrachloromethane

Amitrole

Acetic acid

Hydrogen cyanide (as cyanide)

Methylene chloride; Dichloromethane

Vinylidene chloride; 1,1-Dichloroethylene

Tetraethyl orthosilicate

Acrylic acid; Prop-2-enoic acid

Nitroethane

Bisphenol A; 4,4′-Isopropylidenediphenol

Diphenyl ether

2-ethylhexan-1-ol

1,4-Dichlorobenzene; p-Dichlorobenzene

Acrolein; Acrylaldehyde; Prop-2-enal

Methyl formate

But-2-yne-1,4-diol

Tetrachloroethylene

Ethyl acetate

Sodium cyanide (as cyanide)

Potassium cyanide (as cyanide)

Diacetyl; Butanedione

Carbon monoxide

Calcium dihydroxide

Calcium oxide

Sulphur dioxide

Lithium hydride

Nitrogen monoxide

Nitrogen dioxide

Terphenyl, hydrogenated

Skin absorption feature of ten substances is noted.

Of the 33 substances above, 4 were already listed in the Annex to Commission Directive 91/322/EEC, one was listed in the Annex to Commission Directive 2000/39/EC and one in the Annex to Commission Directive 2009/161/EU. The establishment of new indicative limit values was recommended by SCOEL for the above six substances listed in the Annex to this Directive. They will be deleted from the Annexes to the previous directives on 21 August 2018.

The further lists on indicative occupational exposure limit values (in Cardinal Environment EHS Legislation Registers and Law Checklists):

• Commission Directive 91/322/EEC establishing indicative limit values

• Commission Directive 2000/39/EC establishing a first list of indicative occupational exposure limit values

• Commission Directive 2006/15/EC establishing a second list of indicative occupational exposure limit values

• Commission Directive 2009/161/EU establishing a third list of indicative occupational exposure limit values

UK – the EH40 list is reissuedhere (and will be added shortly to Registers and Law Checklists)

Ditto the Ireland list is updated, and Continental European Registers and Law Checklists will have their current lists updated.

UK exits the EU (UK-EU Future Relationship White Paper)

UPDATE : Barnier statement following the July 2018 General Affairs Council (Article 50) – here – note his reference to agrifoods (the UK proposal for EU alignment only relates to goods checked at the border, this leaves aspects such as GMOs and pesticides to diverge, as I pointed out below)

Following the Chequers Statement, that has been widely published in UK media, the UK Secretary of State for Exiting the European Union (DExEU) has today (12th July) issued the long awaited UK White Paper setting out the UK proposals for the UK-EU Trade Deal (the Future Relationship).

The Chequers Statement is here.

The UK issued White Paper is here.

Please read these in the context of the EU issued Brexit Preparedness Notices (I have posted about these before) here.

A few points to note in the UK issued White Paper :

(1) Paragraph 30 – the UK seeks participation in the ECHA, EMA and EASA. Re the ECHA, the UK seeks to ensure UK businesses could continue to register substances directly with the ECHA, rather than working through an EU-based representative.

(2) Paragraph 36 – the UK will tailor its food policy (including food labelling) locally.

UK-EU negotiations will re-commence with the EU on Monday.

The UK will bring forward it’s separate White Paper on the EU (Withdrawal and Implementation) Bill shortly. This Bill will give effect to the UK-EU Withdrawal Treaty. Prior to publication by the UK of this Future Relationship White Paper, EU had confirmed 80% of the UK-EU Withdrawal Treaty had been agreed.

The UK Trade Bill and Taxation (Cross-border Trade) Bills return for their Third Reading next week.

UK exits the EU (DEFRA preparations)

Ministerial approval is given [prior to the EU (Withdrawal) Bill Royal Assent] to the following projects – to ensure preparation for all negotiation outcomes :

(1) Delivery of a new national import control system for animals, animal products and high risk food and feed. Scheduled to commence building: mid-January 2018. Estimated cost before Royal Assent: £7m.

(2) Delivery of new IT capability to enable registration and regulation of chemical substances placed on the UK market. Scheduled to commence building: February 2018. Estimated cost before Royal Assent: £5.8m.

(3) Delivery of systems for the licensing and marketing of veterinary medicines. Scheduled to commence building: end-January 2018. Estimated cost before Royal Assent: £1.6m.

(4) Development of a new catch certificate system for UK fish and fish products being exported to the EU on Exit. Scheduled to commence: building end-January 2018. Estimated cost before Royal Assent: £1.0m.

(5) Development of a UK system to manage the quota of fluorinated gases and ozone depleting substances required under the UN Montreal Protocol. Scheduled to commence: March 2018. Estimated cost before Royal Assent: £0.5m.

(6) Development of data exchange arrangements to identify the movement of EU and third country vessels in UK waters and the movement of UK vessels in EU or third country waters. Scheduled to commence: April 2018. Estimated cost before Royal Assent: £0.1m

Note : regarding start dates – the Permanent Secretary letter is dated 18 January 2018 – here.

The Civil Service World article dated the next day confirms approval was given on the 18 January 2018 for these projects. The CSW article is here.

Insecticide Restrictions Upheld (EU)

The General Court of the European Union this morning confirmed the validity of the restrictions introduced at EU level in 2013 against the insecticides clothianidin, thiamethoxam and imidacloprid (neonicotinoids) because of the risks those substances pose to bees.

However, it largely upheld the action brought by BASF and annulled the measures restricting the use of the pesticide fipronil, since they were imposed without a prior impact assessment.

The press release is here.

The General Court (EGC) is a constituent court of the Court of Justice of the European Union.

The European Commission had already decided on 27 April to extend existing measures to ban the outdoor use of the three neonicotinoids, after realising the necessary qualified majority among EU member states. Information about this is here.

18 member states, including France, Germany, Italy and the UK, endorsed the Commission proposal to further restrict the use of the three active substances used in pesticides (Bayer’s imidacloprid and clothianidin, and Syngenta’s thiamethoxam).

The countries that voted against were Hungary, Romania, Denmark and the Czech Republic.

The new ban on outdoor use will be in effect by the end of 2018.

Carcinogens and Mutagens (EU)

I posted in 2017 about new developments with the European Carcinogens and Mutagens Directive (2004/37/EC). Find this in the Chemicals archive on this Blog.

A new proposal is now made (the third legislative amendment since the start of this European Commission. Note : the Directive was already amended before these current developments). This third amendment is here. In total, there are three current amendments outlined in this Blog post.

Apart from the third amendment, two previous legislative amendments were proposed by the Commission, in May 2016 and January 2017. Together they proposed limit values to 20 carcinogens. The first of these proposals (the 2016 one) was adopted by the co-legislators as Directive (EU) 2017/2398 (which is an amendment to Directive 2004/37/EC).

NB : Member States have until the start of 2020 to implement Directive (EU) 2017/2398.

The first revision adds 13 new or stricter exposure limits to the EU Directive. Respirable crystalline silica dust, benzene and vinyl chloride monomer are three of the substances affected.

The second proposal for legislative amendments (the 2017 one) is currently being discussed by legislators. The second revision sees new binding occupational exposure limits (Boels), and in some cases skin notations set for:

trichloroethylene;

4,4-methylenedianiline;

epichlorohydrine;

ethylene dibromide;

ethylene dichloride; and

mixtures containing benzo(a)pyrene.

As part of this latest (third) amendment to the CMD, five carcinogens of high relevance for the protection of workers are selected:

• Cadmium and its inorganic compounds;

• Beryllium and inorganic beryllium compounds;

• Arsenic acid and its salts, as well as inorganic arsenic compounds;

• Formaldehyde;

• 4,4′-Methylene-bis(2-chloroaniline) (MOCA).

Background

The EU principles of worker protection from carcinogens are laid out in the over-arching Occupational Safety and Health (OSH) Framework Directive 89/391/EEC and those Directives specifically dealing with chemical risks – notably the Chemical Agents Directive (CAD) and the Carcinogens and Mutagens Directive (CMD).

Under the OSH framework, risks to the safety and health of workers must be eliminated, or, if total elimination is not possible, reduced to a minimum. Employers must identify and assess risks to workers associated with exposure to specific carcinogens and mutagens at the workplace, and must prevent exposure where risks occur. Where this is technically possible, substitution with a non- or less-hazardous process or chemical agent is required. In cases where such substitution is not possible, chemical carcinogens must, as far as it is technically possible, be manufactured and used in a closed system to prevent workers’ exposure. Where this is not possible either, worker exposure must be reduced to as low a level as is technically possible.

The Carcinogens and Mutagens Directive (CMD) sets a number of general provisions to prevent or reduce exposure for all carcinogens and mutagens falling under its scope. In addition to these general minimum requirements, the CMD indicates occupational exposure limit values (OELs) for all those carcinogens or mutagens for which this is possible, as an essential means to protect workers.

From time to time, there are revisions proposed to the CMD (and the CAD).

Email Alerts

Email Alerts are issued closer to the date when Member States must implement the changes to the EU law. Otherwise, please continue to follow this Blog.

Brexit

The first of these amendments must be implemented by early in January 2020. It is not known if the UK will implement this amendment.

UK exits the EU (third country status)

I posted several times regarding EU Notices and Notices from EU regulatory agencies. These remind that the UK will be a third country (as respects the EU) on exit at 12pm CET 29th March 2019. If you have not already done so, please read these Notices.

Any Transition Period that is agreed is in the context of the EU-UK Withdrawal Treaty, and will continue certain EU arrangements only.

One of the aspects is UK membership of EU regulatory agencies (third countries are not members of EU regulatory agencies).

On 11th April 2018, the European Medicines Agency (EMA) confirmed that the EU27 member states and the EMA had completed the task of redistribution of the UK portfolio of centrally authorised medicine and veterinary products. The UK will not be a member of the EMA on its exit. Arrangements were already in place to relocate the EMA (from the UK) to an EU27 member state.

Please read the information that is published about this redistribution here.