The pressure is on

Any company or entity involved in the manufacture of completely ‘new’ products will understand that assessment and compliance with relevant EU product safety directives is mandatory. 

Pressurised fire extinguishing products, including portable fire extinguishers, must comply with the Pressure Equipment Directive (PED) 2014/68/EU, transposed into UK law by SI 2016 No.1105 (The Pressure Equipment (Safety) Regulations 2016). 

The regulations are an important assessment of the safety of pressure equipment and cover all non-exempt pressure equipment sold in the UK with a working pressure greater than 0.5Bar (7.5psi). Assessment against the requirements covers many aspects of a product's safety, including construction and materials used, together with a comprehensive list of ‘essential safety requirements’ (ESR’s) which must be complied with.

Compliant equipment carries a CE mark, confirming it has been assessed against the regulations, under the scrutiny of a Notified Body who issues the confirmatory certificate. 

Therefore, when the author's company was asked to supply components to a 3rd party, undertaking refurbishment / overhaul activities on pressurised fire equipment, originally manufactured and assessed against the regulations by another OEM, we declined.

I think the explanation we gave may be useful to others:

Firstly, it must be made clear that some repair activities do not necessarily impact on the original assessment against the regulations made by the OEM and if the product is re-introduced into service under the same OEM brand under which it was originally assessed, there is no issue.

However, it is clear there is some considerable confusion in the fire industry, with regard to overhaul activities, and obligations under The Pressure Equipment (Safety) Regulations 2016.

It is the definition of a ‘new’ product that is an issue and may be allowing illegal fire extinguisher products to be sold into the EU market, including the UK.

Before we make any assessment against UK law by reviewing the Statutory Instrument, we must first review the Official Journal of the European Union.

In the ‘Blue Guide’(Reference 1), Section 1.5 (Page C272/14),  there is a list of harmonised EU legislation that includes the various Product Safety Directives, including the PED.

Importantly, there are several references in the Blue Guide that potentially re-define the status of the company or entity performing an overhaul activity as a ‘manufacturer’ and an overhauled product as ‘new’, with consequential requirements to re-assess and certify compliance of the ‘new’ product to the legislation; in the case of portable fire extinguishers, to CE mark them.

The definition and responsibilities of a ‘Manufacturer’ 

Reference (1) – Page C272/28 – 3.1 Manufacturer 

“The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark”.

“The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements”.

“When placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State”. 

“The manufacturer must cooperate with the competent national authorities in charge of market surveillance in case of a product presenting a risk or being non-compliant”.  

Reference (1) – Page C272/16 - 2.1 Product Coverage – 5th paragraph

“In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions of the laws concerned, and for fulfilling all the requirements of the legislation in relation to the assembly, the EU declaration of conformity and CE marking. The fact that components or parts are CE marked does not automatically guarantee that the finished product also complies”.

In conclusion, rebranding a product during repair and or refurbishment activities, means the company or entity performing this activity has adopted the responsibility of a ‘manufacturer’ and rebranding has, in turn, created a ‘new’ product.

The definition of a ‘new’ product

Reference (1) – Page C272/16 - 2.1 Product Coverage – 6th paragraph

“A product which has been subject to important changes or overhauls aiming to modify its original performance, purpose or type after it has been put into service, having significant impact on its compliance with Union harmonisation legislation, must be considered as a new product.”

Reference (1): Page C272/17 - 2.1 Product Coverage – 2nd paragraph.

“In any case, a modified product sold under the name or trademark of a natural or legal person different from the original manufacturer, should be considered as new and subject to Union harmonisation legislation”.

In conclusion, introducing important changes to a product during overhaul activities can also impose the status of ‘new’ on the resulting product and again enhance the status of the company or entity performing this activity to that of a ‘manufacturer’. 

It is often the case that the two most critical pressure retaining components on pressurised equipment are a pressure vessel and a valve. There can be no more important change, with more significance, than when an originally certified valve is replaced by a different manufacturer’s valve, that has not been approved. If this change was proposed by the OEM, then the new valve would, without any question, require re-assessment against the regulations. For this reason, any replacement of a certified valve with a different valve during overhaul activities will, it is clear, require the same treatment and re-assessment in accordance with regulations, because in doing so you have created a ‘new’ product. 

The status of various parties in UK Regulations

It is important that we define the status of each company or entity that is impacted by the regulations

(Reference (2)).

Page 2 - “economic operator” means a manufacturer, an importer or a distributor.

Page 3 - “manufacturer” means a person who

(c) manufactures pressure equipment or an assembly, or has such equipment or assembly designed or manufactured; and either

(d) markets that pressure equipment under that person’s name or trade mark; or

(e) uses it for his own purposes.

Page 2 - “distributor” means any person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or an assembly available on the market.

Actions required for non-compliant equipment

See Reference (2) Page 9:

“17. (1) A manufacturer who considers, or has reason to believe, that pressure equipment or an assembly which that manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to

(a) bring the pressure equipment or assembly into conformity;

(b) withdraw the pressure equipment or assembly; or

(c) recall the pressure equipment or assembly.”

See Reference (2) Page 14

“34. (1) A distributor who considers, or has reason to believe, that pressure equipment or assemblies which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to

(a) bring that pressure equipment or assembly into conformity;

(b) withdraw the pressure equipment or assembly; or

(c) recall the pressure equipment or assembly.”

Overall conclusions

• If a product is rebranded by removing the OEM brand, during overhaul activities, then it is a ‘new’ product and requires re-assessment against the relevant EU Product Safety Directive and should show the corresponding mark e.g. CE mark. Any company or entity that does this, adopts the status of a ‘manufacturer’.
• If a product undergoes an overhaul / refurbishment procedure that introduces important changes, then the product will require assessment against the requirements of the regulations as a ‘new’ product. Any company or entity that does this, adopts the status of a ‘manufacturer’.
• The outlined position, whilst mentioning a specific product safety directive, has significant implications for products in a variety of industries. It is the responsibility of ‘economic operators’ involved in any activities relating to overhauling, renovating, refurbishing or distributing products to satisfy themselves they are fully compliant with relevant EU Product Safety Directives and take the necessary steps to comply with their legal obligations.

How to recognise non-compliant portable fire extinguishers

Compliant product must carry a CE mark for the overall product assembly. This will normally be included in permanent printing or labelling. 

Manufacturers of compliant products will be able to supply the relevant conformity assessment certification, if requested, since the correct legal status of installed products is a pre-requisite for all persons in the supply chain. 

The absence of a CE mark and a relevant certificate will identify a non-compliant product.

Note: Individual components such as cylinders or valves may carry a CE mark, but this does not confirm compliance with the regulations for the assembled product. 

Regulatory oversight

Anyone with concerns about products not meeting the regulatory requirements should contact the relevant market surveillance authorities, to consider whether this is a matter for investigation. In the UK these are:  

1.        Health and Safety Executive for equipment in the workplace: http://www.hse.gov.uk/

2.        Trading Standards for equipment for consumers or private use: https://www.gov.uk/find-local-trading-standards-office

References

1. Blue Guide : https://ec.europa.eu/docsroom/documents/18027

2. SI 2016 No.1105 (The Pressure Equipment (Safety) Regulations 2016) - PER. https://www.legislation.gov.uk/uksi/2016/1105/pdfs/uksi_20161105_en.pdf

(* ‘Products’ will be identified by a relevant approval mark, such as a CE mark. Other markings could be applicable, depending on the relevant directive).

Craig Halford is managing director of Jactone Products Ltd. For more information please visit: