Navigating industry regulations

Since then, we have had a subsequent change of administration. This brings with it some fresh challenges, not least the big picture change of focus and prioritisation.

2019 saw Civil Service re-structuring, with the loss of BEIS (the Department for Business, Energy and Industrial Strategy) and the creation of DBT (the Department for Business and Trade) and the DESNZ (the Department for Energy Security and Net Zero).  Some of the responsibilities for enforcement now rest with Defra (the Department for Food and Rural Affairs) and EA (the Environment Agency). 

UKCA and CE Marking

In May 2024, a Statutory Instrument (S.I. 2024/696) was passed through parliament.  This will come into force on the 1 October 2024, allowing the placing of CE marked equipment on the GB market ‘indefinitely.’

The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696) covers regulations for (but not limited to) machinery, pressure equipment, simple pressure vessels, EMC compatibility, PPE and electrical equipment. This means that the UK/GB market (Northern Ireland continues to have its own specific set of rules) can continue with the status quo of supplying goods with CE markings applied, without the need for costly duplicate UKAB (‘Authorised Bodies’, vs the EU NoBo = ‘Notified Bodies’) assessment requirements in most instances.

Regarding European activity, BCAS continues to support the activities of Pneurop, as the majority of European directives still apply in most cases. 

Most of the product we work to support is European manufactured and we continue to push for alignment. It would appear that this message has been listened to and with new regulation in the EU, we have an open door for conversation and consideration which had not always been the case. Working with other associations such as EURIS and EAMA allows a wider machinery and engineering voice to be presented when lobbying on topics relevant to our industry.

Specific topics currently under scrutiny are:

EU F-Gas

While the current UK F-Gas situation is unclear, as we currently follow the 2014 EU Regulation which was transposed into UK Law, the EU F-Gas Regulation has been revised. 

When the latest revision of the EU F-Gas Regulation was published in February 2024, Pneurop PN14 (Air Treatment Committee) generated a technical position paper. The intention of the paper was to clarify the classification of Compressed Air Refrigerated Dryers (CARDs) as the F-Gas Regulation doesn’t recognise the CARD product/application. 

So, at a ‘local’ level with EU Member States, which does not include UK/GB as it is classed as a ‘third country’, there is a risk that enforcement agencies could apply their own interpretation and disagree with the PN14 position paper. 

This position paper has been endorsed by the Commission, in so far as DG CLIMA has said that the logic is ‘defendable’,  but the very next comment was “Still, we need to underline that only the Court can make binding interpretations of EU law”. So, we don’t necessarily have a complete endorsement, but we do have a position of support toward the logic applied to the argument.

BCAS continues to work closely with Pneurop and Orgalim on the next steps, which could be a possible derogation for four years, and PN14 is preparing another position paper on that topic.

EU REACH (PFAS)

PFAS (per and poly fluoroalkyl substances) are currently a global hot topic. Known as “forever chemicals”, these substances are in widespread use, most commonly in oil and water repellent textile treatments.

They are also used throughout many industries and applications, are ‘persistent’, and have known health risks. PFAS substances used commonly in the compressed air industry include HFC refrigerant gases (used in compressed air refrigerated drying), common sealing compounds (PTFE, FPM, etc.) and coatings such as anti-friction treatments used for meshing metallic components.

BCAS was involved in this topic initially at European level (PN14 - Air Treatment) for applications using paper filter media. PN14 then expanded the topic to the other Pneurop Committees and a series of position papers were published. 

The biggest single affected application for the compressed air market is F-Gas, which is already regulated. But the implications for the common sealing compounds, which will potentially affect all machinery manufacture and installation, are more wide-reaching. 

There was an EU REACH/ECHA public consultation that closed in September 2023, which received over 6,000 unexpected and unprecedent responses and saw the submissions portal crash under the heavy load. More than 5,000 of these responses came from private companies, trade associations, academic institutions, NGOs, member states, and trade unions.

The Pneurop/BCAS response was that the blanket approach is not appropriate, and needs to be considerably more granular in its approach. The ECHA Risk Assessment & Socio-Economic Committees are significantly delayed, and the individual national authorities are reviewing their approaches.

EU PED / EU SPVD

The Swiss/French national authorities have made public comments that the EU SPVD is being applied incorrectly and proposes a merger of EU SPVD into EU PED. They claim that some compressor manufacturers try to classify compressor pressure vessel components, such as oil separators, as EU PED by defining a second fluid, where the EU SPVD definition is ‘to contain air or nitrogen.’ 

EU SPVD is well established for over 30 years, and with an estimate that three million compressors have been placed on the market, the health and safety  obligations are clearly understood and executed.

EU PED does not include the design, approval and production control phases for smaller vessels which are produced in that highest quantities. It is estimated that 30 per cent  of equipment placed on the market will be EU PED Cat I and market surveillance authorities have recorded ZERO safety incidents.

Concerns

Safety expectations for smaller vessels will likely be diminished and the extra cost burden will likely be placed on compressor manufacturers due to the EU PED assembly classification. Pneurop Working Group PN06 (pressure vessels) is developing an EU PED/EU SPVD position paper so that the different market sectors, including PN02 compressors and PN14 air treatment can align effectively. 

The European Commission has not yet stated its intention (there has been a call for ‘evidence’, which is being reviewed, but Pneurop PN06 is are preparing for all possible eventualities.

Machinery Regulation

The new Machinery Regulation (EU/2023/1230), which replaces the current Machinery Directive (2006/42/EC), was adopted on 14 June 2023. All machinery placed on the market before 20^th January 2027 must comply with the current Machinery Directive, but manufacturers are also allowed to state on an EU Declaration of Conformity that such machinery also conforms with the new Machinery Regulation, if applicable.

This sets out to update the 2006 regulation by including concepts such as paperless supply, except for basic safety information for non-professional users, which could allow documentation to be accessed digitally via a QR code, and machine-learning (AI), particularly where the learning techniques ensure safety functions.

It also sees a change in the legal status as a regulation does not require transposition into local national law, as directives do. This falls into line with the New Legislative Framework (NLF) which sets out the main rules for market surveillance and conformity assessment bodies.

EU Harmonised Standards

An interesting development in the world of Harmonised European Standards (HeNs) is that there has been a legal challenge made to the European Court of Justice by an American public domain advocate, called Carl Malamud.  Malamud applied the concept to the safety of toys regarding the legal status of harmonised standards requiring the free availability (i.e. free of charge) of the published standards. 

This goes against the established commercial model of the National Standards Bodies (NSBs), such as BSI, DIN and ANSI, who incur costs in the development of said standards and balance their costs by the generation of revenue through the legitimate sales of said standards to end users.

The legal action was recently appealed but upheld, so the NSBs are reviewing currently how they support the development activity of ISO standards which become adopted HeNs and looking to revise their commercial models.

With all this activity ongoing it is more important than ever that you remain in touch with the proposed changes and have your say on what could be our new legislative landscape. 

As the independent trade association for the compressed air and vacuum industry, BCAS can provide the most accurate source of information alongside technical experts to enable specific industry queries to be answered.

Tim Preece is technical officer at BCAS

www.bcas.org.uk

Tel: 0207 935 2464