Plastic Microbeads in Cosmetics Ban (UK)

UPDATE 3rd August : the 2017 Regulations are now notified to the EU and to the WTO. The EU notification gives detail, and is here

A few days ago, the DEFRA Secretary of State confirmed the UK will introduce a ban on plastic microbeads in cosmetics and personal care products. Following consultation, the proposals are summarised :

(1) the ban on manufacture (England) will start 1st Jan 2018 and the ban on sale (England) will start 30th June 2018

(2) precise definitions of “microbead”, “plastic” and “rinse-off personal care product” have been developed to clearly define the scope of the ban

(3) the scope of rinse-off products will be as set out in the consultation, but DEFRA is additionally working with the Hazardous Substances Advisory Committee (HSAC) to assess the case for addressing further categories of products

(4) Trading Standards will be the regulator to manage compliance and enforcement in England

(5) enforcement in England will be carried out through a range of sanctions including variable monetary penalties, compliance notices, stop notices and enforcement undertakings

(6) the Devolved Administrations (Scotland, Wales and Northern Ireland) will consider appropriate enforcement mechanisms, regulators and timescales according to devolution settlements.

The summary of DEFRA responses is here.

Legislation is expected by the end of 2017. This is a UK initiative, and is unconnected with the EU. 

UK exits the EU (medicines and veterinary products)

On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.

The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :

(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),

(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,

(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,

(4) active substances manufactured in the UK will be considered imported active substances, 

(5) medicinal products manufactured in the UK will be considered imported medicinal products, 

(6) batch release sites (for certification) must be located in the EEA. 

New European Carcinogens and Mutagens Directive (EU)

A further stage is reached yesterday in the creation of a new EU Directive to amend the existing Directive on this topic to introduce stricter limits on exposure values and skin notations for five carcinogens as well as skin notations independently of limit values for two more carcinogens, covering seven carcinogens in total.

The carcinogenic and mutagenic substances covered by the directive are the following: Mineral Oils that have been used before in internal combustion engines, certain polycyclic aromatic hydrocarbons (PAHs) mixtures, trichloroethylene, 4,4′-methylenedianiline, epichlorohydrine, ethylene dibromide, ethylene dichloride. 

The European Commission had submitted in January 2017 the proposed revision which concerns in particular annexes I and III of directive 2004/37/EC. 

The retained limit values are based on an analysis of economic, social and environmental impacts of the different policy options for each chemical agent, on the criteria of the scientific advice of the scientific committee on occupational exposure limits (SCOEL), effectiveness, efficiency and coherence. 

The limit values were also agreed by the advisory committee on health and safety at work (ACSH). 

This revision follows an earlier Commission proposal which already included 13 carcinogenic agents.

A further package of proposed limit values is expected to be adopted by the Commission at the beginning of next year. 

The current documents are found here

TSCA Reform (Chemicals) (US)

The U.S. federal Toxic Substances Control Act (TSCA) regulates chemicals in common use that are present in electronics, furniture, clothing, toys, building materials, cleaning and personal care products, and most household items. It was enacted in 1976, and – in spite of the introduction of thousands of new chemicals, as well as the major progress made in the understanding of chemicals’ environmental and health impacts – it hasn’t been updated since then.

Attempts are being made to reform the TSCA, to modernise it and to update it.

The Guardian has a useful article aimed at providing a laypersons summary, here.

A more in depth summary of the legal developments is collated and published by the American Bar Association, here.

HSE Injuries and Fatalities Roundup (UK) (7 Jan)

Poor gas repair work leads to gas ignition which put the injured person in a coma for three months – HSE said: “Mr Smith suffered horrific injuries in the explosion which will affect him for the rest of his life, but he could easily have been killed. Having burnt through the cables while using a blow torch, it would have been obvious to Mr Laffin that the cables were severely damaged. He should have made sure they were properly repaired but instead he just wrapped them in tape. Mr Laffin clearly wasn’t competent to carry out electrical work, and he should have brought in an electrician if he didn’t know what he was doing. Working with gas and electricity are classified as specialist trades for a reason, and it’s therefore vital workers stick to their area of expertise so lives aren’t put at risk.” HSE Press Release is here.

Pipe rupture causes acid burns – HSE found the company had failed to make sure its pipework – the company has around 9,250 metres of it – was in a safe condition and corrosion had been allowed to take hold of the section that carried the acid. HSE Press Release is here.

Work at height fall causes severe injuries – HSE said: “The dangers of working at height are well known, yet workers undertaking roof work and building maintenance sometimes die or are permanently disabled because of the poor safety standards and lack of safeguards that still exist among some contractors. It is essential that the hazards associated with working at height are recognised and understood by the client who commissions the work. The client must make sure the individual or company they employ is competent to carry out roof work and is aware of the hazards and precautions that need to be taken for the work to be carried out safely. Geoff Thompson did not properly assess Mr Davies’ arrangements for health and safety and determine whether he would be able to do the work safely and without risk. This prosecution should serve as a reminder to all involved in construction projects, including clients, that they have a legal duty to ensure work at height is properly planned and robust safety precautions are put in place.” HSE Press Release is here.

Drain cleaner sodium hydroxide causes skin burns – HSE investigation found a leisure centre operator had failed to put a robust system of work in place for cleaning drainage in the changing room for a swimming pool. This system should not only have included clear instructions on how the drains should be cleaned, but also established whose responsibility it was to clean drains. The company also failed to properly assess its use of chemicals and provide proper training on the use of these chemicals. HSE Press Release is here.

Forklift truck reversing results in fatality – Mapei UK Limited of Steel Park Road, Halesowen, pleaded guilty to breaching Sections 2(1) and 3(1) of the Health and Safety at Work etc. Act and was fined a total of £173,332. The amount of costs to be paid will be agreed at a later date. HSE said: “Numerous health and safety failings by Mapei UK Ltd led to this tragic incident in which Mr Davies needlessly lost his life. The dangers associated with vehicle movements are obvious and have been highlighted by HSE for many years. There were long-term, systematic failings by the company to adequately assess the risks and take sufficient control measures to ensure the transport yard was operated without posing a risk to the safety of those working there. Since Mr Davies’ death, Mapei UK Ltd has implemented more effective controls of vehicle movements, limiting movements to one vehicle at a time and installing a traffic marshal to supervise vehicle manoeuvres. The operation which Mr Davies was carrying out is also now done away from other vehicles.” HSE Press Release is here.

Fall from tractor causes serious injuries – the injured person had been standing on the cross shaft arms at the back of the tractor when he fell, resulting in one broken and one shattered wrist, two broken arms and multiple skull fractures. He underwent several operations to put pins and plates in both arms and was unable to work for over a month. HSE found the agricultural sales company had not provided any measures to prevent falls. There was no plan for the work, no safe system of working and no suitable training or supervision. HSE Press Release is here.

Unauthorised scaffolding guardrail adjustment leads to a co-worker fall which broke his back – HSE said: “What happened that day could easily have been avoided and will affect the injured man for the rest of his life. Scaffolding should only be altered by scaffolders, but a colleague took it upon himself to adjust some scaffolding when he was not authorised to do so, with disastrous consequences. He had no ulterior motive – like most construction workers he was simply trying to get on with the job when a problem arose that he was trying to overcome. The consequences of the incident have had a huge impact upon him as well. I hope this case makes construction workers stop and think before putting themselves and their colleagues at risk by altering scaffolding on building sites.” HSE Press Release is here.

Poorly secured forklift load causes crushing injury – HSE said: “This was an entirely preventable incident which resulted in an employee having to have part of his leg amputated. His whole life has been affected by the shortcomings of this company. No effort was made to plan the work in advance, despite it being a highly unusual activity for employees at the factory. The firm should have considered the risks and found a safe way of moving the fish tank. If it had been secured to a pallet and loaded onto a larger vehicle, rather than a van, than the terrible injuries the worker suffered could have been avoided.” HSE Press Release is here.

Machinery guarding failures leads to entrapment – HSE said: “The company failed to guard this machine and the gap was large enough to allow the worker access to dangerous moving machine parts. Sadly for her this incident was both foreseeable and preventable. Luckily, colleagues were quickly able to release her, which minimised her injuries. However, it has had a massive impact on her and she has only recently returned to work, some 18 months after the incident. This prosecution should send a strong signal to companies to identify and act on the risks presented by production machinery and to review the measures they have in place regularly.” HSE Press Release is here.

Machinery guarding failings leads to serious injury – HSE said: “It is very disappointing that this company had not learned the lessons following a prosecution for a very similar incident and allowed the same failings to continue to exist in a neighbouring department. The process of risk assessment is a vital process to allow a company to identify significant risk and ensure it is complying with the relevant statutory provisions. In this case the process of risk assessment was not suitable or sufficient and this, together with the company’s failure to heed warnings, has meant that a very obvious risk has been left to exist for many years. Preventing access to dangerous parts of machinery is long established and there are ample guidance and industry standards to allow dutyholders to achieve compliance with the law. This incident was entirely avoidable and the worker should have been better protected by his employer.” HSE Press Release is here.

Machinery guarding failings again leads to serious injury – HSE inspector said: “Mr Howkins’ life has been devastated by the horrific injuries he sustained as a result of The Artisan Press failing to effectively prevent access to dangerous moving machinery. Incidents where workers are injured, or even killed, by moving machinery are easily avoided if employers provide suitable guarding. Effective measures were not taken by The Artisan Press Ltd to prevent their workforce from accessing dangerous moving parts, in this case the stacker and sword drive mechanism. In addition, safe systems of work, information, instruction and training are required to control the risks during both production and maintenance activities.” HSE Press Release is here.

Another work at height fall causes injury – HSE Inspector said: “The worker sustained a serious injury that could have been avoided had a safer system of work been used for removing the fragile sheets. The risk of serious or even fatal injury is high and eminently foreseeable with this type of work, and it is vital that the correct equipment and methods are in place. The company eventually got it right by working from inside the building and avoiding the need to physically go onto the roof, but it is sad that it took a serious incident before this happened.” HSE Press Release is here.

Methyl iodide exposure causes serious injury – HSE Inspector said: “The multiple failings arising from this prosecution are extremely serious and could have had even more devastating consequences. Two of those exposed to methyl iodide have been left with permanent, life-changing after effects. The lack of competent management, control and understanding of the site’s major hazard and chemical processes could have led to these being fatal investigations, as could the incident to the workers who were exposed to methylene chloride. Euticals Limited and Archimica Chemicals Ltd, were fully aware of the standards required to protect workers and ensure that equipment, systems and processes were fit for purpose, yet there is clear evidence of systematic health and safety failings over a prolonged period despite continue advice and support from the regulator to gain compliance. Health and safety should not be neglected, overlooked or compromised, especially in a high risk environment where there are hazardous and dangerous substances.”

Natural Resources Wales said: “Companies that deal with potentially hazardous chemicals, like Euticals Ltd, have permits with strict conditions in place to protect the local communities and the surrounding environment. Despite advice and support from our officers, the company consistently failed to meet the conditions and standards we set, placing local people, the environment and their own staff at risk.”

HSE Press Release is here.

Hand Arm Vibration Syndrome (HAVS) detected – HSE Inspector said: “A number of employees of Onesubsea UK Ltd developed debilitating symptoms or suffered worsening of existing symptoms. As a result the lives of some have been forever changed. HAVS is preventable but once the damage is done, and it can be permanent. Focus should be placed on eliminating or controlling exposure to vibration. There are cost-effective and simple ways of reducing the risk of HAVS which should be implemented. A good health surveillance system is vital to detect signs of vibration-related symptoms at an early stage. It is imperative that management then respond actively and appropriately to any such signs. Onesubsea UK Ltd did not comply with their statutory duties for a period of several years despite being aware of the risks associated with the use of vibrating hand tools. Their management of health and safety fell well below acceptable standards and a number of workers are now paying the price. HAVS is serious and disabling, and nearly two million people are at risk. Damage impacts on hand and finger dexterity, including the inability to undertake minor day to day tasks, and cold can trigger painful finger blanching attacks.” HSE Press Release is here.

Long-Chain Perfluoroalkyl Carboxylic (LCPFAC) Chemicals (US)

Significant New Use Rule issued today by the USEPA, under the US federal Toxic Substances Control Act, requires that anyone who intends to manufacture (including import) or process any long-chain perfluoroalkyl carboxylic (LCPFAC) chemicals for use in carpets or carpet products submit a notification to EPA at least 90 days before beginning the activity, providing the agency with an opportunity to review and, if necessary, place limits on manufacturers or processors who intend to reintroduce or import products with these chemicals.

Today’s action is one of several the USEPA has taken to protect the public from perfluorinated chemicals. In 2006, the eight major U.S. companies producing LCPFAC chemicals committed to the EPA’s voluntary PFOA Stewardship Program, pledging to reduce global emissions and product content of LCPFAC chemicals by the end of 2015. As part of this phaseout program, the industry stopped using LCPFAC chemicals on carpets and aftercare treatment products. EPA has also issued other Significant New Use Rules to require EPA review and prior to the reintroduction of other perfluorinated chemicals included in the voluntary industry phaseout. EPA anticipates another Significant New Rule on additional perfluorinated chemicals in early 2014 as well as Significant New Use Rules on other chemicals that will include imported products.

Here is the USEPA information on its perfluorinated chemicals (PFC) action programme.

Here is the pre-publication copy notice of the LCPFAC rule.