Regulatory Compliance

UK & EU Biocidal Product Regulations

We are experts in navigating the UK and EU biocide regulations. This niche specialism allows us to guide customers to compliance, highlighting common pitfalls and bottlenecks.
Our equipment is designed to meet or exceed all relevant regulations and legislation and forms a solid foundation for compliance.

(UK) HSE Biocides – The Law (EU) Regulation No. 528/2012

Regulations

Focus on | Formalin

Legal Status

Safety

Rules & Guidance

Benefits

The Facts

Approval Status

Formalin (aqueous Formaldehyde) has been the ‘gold standard’ sanitiser for over a century but has suffered regulatory confusion in recent years.
On 01/02/2022, Formaldehyde was approved for use under the EU and UK Biocidal Product Regulations (BPR), in product types PT2 and PT3:

  • PT2: Disinfections not for application to humans or animals (surface cleaning etc.)
  • PT3: Disinfectant for veterinary hygiene in areas in which animals are housed, kept or transported (including the disinfection of eggs)

The path to this approval status has been long, starting with a dossier prepared in 2007-2008.

This lengthy approval process was blamed for some confusion regarding the legality of Formaldehyde. Thankfully now the process is complete and the status is clear.

Biocidal Products Committee

BPC Highlights

The Biocidal Products Committee (BPC) prepares the opinions of the European Chemicals Agency (ECHA) which ultimately guides the approval of biocides in the EU and UK.

Their report on Formaldehyde highlights several key points from consultations and preparatory work:

  • “Formaldehyde is effective against a broad antimicrobial spectrum.”
  • “Formaldehyde is non-corrosive and exhibits good material compatibility”
  • “It is biodegradable and not persistent, stable during storage.”
  • “Formaldehyde has superior penetration properties”
  • “The fumigated substance can reach all inaccessible areas and crevices in the animal facility. It enables a high control of infectious diseases.”
  • (alternatives are) “at least 10 times more expensive than Formaldehyde”
  • all alternative products are ineffective by comparison to Formaldehyde or damaging to the chick/egg.

Safety & Marketing

Alternatives

Some manufacturers offering alternatives have also encouraged users to believe that Formaldehyde is more dangerous than their products. Unfortunately it is very unlikely that any chemical sanitiser can be thought of as a ‘safe’  product when its function is dependent on it being rather ‘unsafe’. If a chemical kills micro-organisms (bacteria etc), it’s quite certain to do macro-organisms (including humans) significant harm if unmanaged. All hazardous chemicals must be professionally managed for safety and compliance, whether they contain Formaldehyde or not.

Glutaraldehyde Quaternary Ammonium

Smallprint

Conditions For Use

Formaldehyde’s active substance approval documents highlight the importance of proper management for the professional user. To comply with the regulations, there are conditional elements written into the approval documents:

  • You must avoid exposure to workers
  • You must provide an exact dose only
  • You must use an automated system
  • You must have concentration safeguards in place

Within the UK, it is also expected that use will be restricted to those classified as “Professional with demonstrated competence”.

Our systems provide a unique backbone for compliance with all the above criteria.

Case Studies

  • “It’s absolutely amazing. Implementing Sonas for me has been a no-brainer!”

    Avara Foods Ltd

    D.Neilson, Agriculture Director
    View Case Study
  • The equipment used to suppress pathogens in poultry agriculture has been given an upgrade, with Grundfos pumps at the heart of the improvements.

    Grundfos Pumps Ltd

    John Manwaring, Area Sales Manager
    View Case Study
  • Where specialist components are required, Sonas uses pipe and fittings provided by EM-Technik, the world’s leading manufacturer of chemical resistant fluoropolymer connectors and fittings.

    EM-Technik UK Ltd

    Malcolm Grimes, Managing Director
    View Case Study

System Effects

Impact Areas | Features & Benefits

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