UV processes in production: regulatory requirements for validation, monitoring, calibration and documentation

The regulatory framework in Germany and the EU – a sector analysis and market assessment for UV measurement.

As the regulatory control of manufacturing processes tightens, the role of UV measurement changes with it. What matters is no longer only whether a UV source works, but whether it can be demonstrated, for quality-critical processes, that the required process conditions are met reproducibly. Irradiance, UV dose, spectral distribution, exposure time and the long-term stability of the UV source are the decisive quantities.

The analysis concentrates on Germany and the European Union; selected comparisons with the United States (food irradiation) and international shipping (ballast water) complete the picture.

The report sorts the regulations by how directly they reach into the UV process, works through the affected sectors one by one, names the cross-cutting regulation that applies to UV systems, and closes with a timeline for the next 18 months.

UV radiation acts by purely physical means. Two consequences follow from this, and they shape all further regulation.

Not a biocidal product – with one exception

Pure UV irradiation is not covered by the Biocidal Products Regulation (EU) No 528/2012, because its Article 3(1)(a) only covers effects achieved “by means other than mere physical or mechanical action”. Unlike chlorine, ozone or peracetic acid, UV light therefore falls outside the authorisation requirement in principle. An exception arises wherever a UV source generates ozone in situ – for example with unfiltered excimer emitters in the vacuum-UV range below 200 nm. In that case the authorisation requirement applies via the active substance “ozone generated from oxygen in situ” – a design risk that is frequently underestimated in far-UVC applications.

No residue on the product – but an obligation to prove the process

Because UV leaves no chemical residue, its effectiveness cannot be analysed on the finished product after the fact. Legislators therefore require the same pattern across all sectors: type-tested or qualified equipment, a validated dose, suitable monitoring and complete documentation. This creates a permanent, recurring burden of proof on the operator.

No general legal obligation to monitor every UV process continuously by radiometric means exists in any of the sectors examined. Instead, the monitoring obligation arises in practice from the classification of a UV process as a critical control point, a critical quality parameter or a validated “special process” within the applicable set of rules.

For practical purposes the regulations can be sorted by how directly they reach into the UV process:

In Germany, UV disinfection is an approved physical disinfection process for public water supply.¹⁷ Approved systems must demonstrate their disinfection efficacy through type testing; the required reduction-equivalent fluence is currently at least 400 J/m², referred to Bacillus subtilis and 254 nm.

Technically this is set out in the DIN 19294 series and the DVGW body of rules (including W 294-1). Testing covers UV radiometers, measuring windows, lamps and ballasts, control technology, the linearity and directional response of the radiometers and – for medium-pressure systems – additionally the spectral selectivity and the disinfection efficacy determined by biodosimetry. With DIN 19294-2:2026-04 and DIN 19294-4:2026-04 the requirements for UV medium-pressure systems were updated in April 2026.¹⁵ For UV-C LED systems the corresponding parts of the series are still being drafted; UV-C LED systems are therefore not yet approved for public water supply for want of a corresponding test basis.

Article 11 of the EU Drinking Water Directive (EU) 2020/2184 sets a hard deadline: on the basis of Implementing Decision (EU) 2024/367, European positive lists of starting substances for materials in contact with drinking water apply from 31 December 2026, combined with harmonised conformity assessment, an EU certificate and EU marking.¹⁸ For nationally approved products a transitional period runs until 31 December 2032.¹⁹ This affects every wetted component of a UV reactor, including quartz sleeves, seals, wiper elements and housing coatings.

For UV LED systems the importance of measurement increases rather than decreases compared with classic low-pressure lamps: LED ageing changes the optical output, temperature influences the emission, individual LED arrays age at different rates, spectral properties become technologically more relevant, and monitoring electrical power alone is not sufficient to determine the biologically effective UV dose. This creates a growth area for OEM radiometers, reference sensors and validation systems for UV-C LED reactors.

The Urban Wastewater Treatment Directive (EU) 2024/3019 (“UWWTD”) entered into force on 1 January 2025 and must be transposed into national law by the end of July 2027.³³ It introduces a fourth treatment stage, which becomes mandatory for plants above 150,000 population equivalents and applies from 10,000 population equivalents in sensitive areas, with staged implementation until 2045.²⁰ The directive also establishes extended monitoring obligations for micropollutants – monitoring thus becomes a legal duty in its own right, with its own cost centre.

Particularly notable is the extended producer responsibility under Articles 9 and 10: manufacturers of pharmaceuticals and cosmetics are to bear at least 80 per cent of the additional treatment costs, and the contributions are explicitly intended to cover investment and operating costs for monitoring activities as well.²¹ For the first time this creates a solvent third party for monitoring outside the classic fee logic – although the legal position is not yet settled, as actions for annulment against it are pending before the General Court of the European Union. UV appears here less as classic disinfection than as a UV/H₂O₂ combination (advanced oxidation process) and, in water reuse, as a barrier subject to validation with log-reduction evidence.

For food businesses, Regulation (EC) No 852/2004 is the central basis. It requires permanent procedures based on the HACCP principles, including the identification of critical control points, the setting of critical limits, effective monitoring procedures, corrective actions, verification and documentation.¹

UV processes are used here for the treatment of surfaces, packaging and closures, process water, air and transport and production systems, among others. Whether a UV process is to be classified as a critical control point follows from the individual operational hazard analysis – a general legal obligation to measure UV continuously by radiometric means does not follow from the regulation itself. If, however, UV is used to control an identified microbiological hazard and is defined as a critical control point in the HACCP system, a process monitoring obligation arises in practice. Operational practice sometimes monitors only whether the lamp is switched on, the lamp current or the operating hours – regulatorily more robust would be the optical dose or irradiance actually applied, since the optical output is considerably influenced by ageing, soiling, temperature, distance, shadowing and product speed.

UV treatment of the food itself – novel food

A tighter regulatory link arises when UV is used not only for disinfection but to change the food itself – for example to increase its vitamin D content. EU authorisations as a novel food exist for UV-treated baker’s yeast, UV-treated bread, UV-treated milk, UV-treated mushrooms and vitamin D₂ mushroom powder, among others.²⁸ In January 2025, Implementing Regulation (EU) 2025/89 added UV-treated powder of whole Tenebrio molitor larvae (mealworm) as an authorised novel food; the authorisation has applied since 10 February 2025.²⁷

The regulatory logic here is particularly strict: the UV treatment changes the chemical composition of the food and thereby becomes part of the product specification. The authorisation for UV-treated baker’s yeast, for instance, sets specific maximum levels of no more than 5 µg vitamin D₂ per 100 g and per day, and even the introduction of additional process steps requires an amendment to the specification.²⁸ UV dose thus becomes a potential critical process parameter whose modification can trigger a new authorisation. Novel food authorisations are also protected for the applicant for five years as a rule.

Regulation (EC) No 2023/2006 on good manufacturing practice for food contact materials requires a functioning quality assurance system and the documentation of relevant manufacturing operations and quality control results.² For printing inks the regulation explicitly stipulates that constituents of the printed surface must not be transferred through the substrate or by set-off to the food contact side if this would breach food law requirements.

With UV-curing printing inks, photoinitiators start the polymerisation; the state of cure depends on the UV spectrum, irradiance, UV dose, web speed, layer thickness, formulation and temperature. Insufficient polymerisation increases the proportion of unreacted photoinitiators and residual monomers, which can migrate. Printing inks are not harmonised across the EU; Germany has created its own positive-list regime with the Consumer Goods Ordinance (Bedarfsgegenständeverordnung).⁵ Until the German provisions take effect, the EuPIA photoinitiator list applies in practice: photoinitiators not on the list should only be used where migration is no more than 10 µg/kg or where a functional barrier is present.⁶ A structural disadvantage of the German route compared with REACH is that there is no mechanism for data or cost sharing – each manufacturer bears the full cost of the data alone.

Controlling the UV process does not replace chemical migration testing, but it can be part of a qualified production process by which previously validated curing conditions are reproducibly maintained. The regulatory lever is therefore: incomplete cure equals potential migration of unreacted photoinitiators. Monitoring the UV dose at the dryer thus becomes the de facto point of proof for food contact compliance.

Germany: tighter printing ink rules from 1 January 2027

A narrow window with concrete deadlines is opening for the German market. The Consumer Goods Ordinance was amended by an amending regulation of 19 December 2025; the new provisions for printing inks on food contact articles largely apply from 1 January 2027, after the transitional period originally envisaged for 2026 was extended.³ In future, Section 4 of the ordinance will explicitly govern substances in printing inks, including monomers, colourants, solvents, additives and photoinitiators; specific migration limits are set for certain substances, and for substances not listed a non-detection limit of 0.01 mg/kg food applies in the case of indirect food contact.⁴ Sell-off arrangements exist for products already lawfully placed on the market.³⁵

The more strictly residual monomers and photoinitiators are regulated, the more important reproducible, complete polymerisation becomes – and with it, indirectly, UV dose as a compliance-relevant process parameter. For printers and packaging manufacturers this allows a proof of process under food contact GMP to be positioned instead of plain “UV measurement”, consisting for example of an inline UV sensor, dose monitoring, integration of the web speed, alarm limits, a batch record and a calibration concept.

The PPWR reinforces the trend

Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) entered into force on 11 February 2025 and has applied directly in all Member States since 12 August 2026.⁸³⁴ Article 5 requires in principle that the presence and concentration of substances of concern in packaging materials be minimised; for food contact packaging, specific PFAS limits have applied in addition since 12 August 2026.⁹¹⁰

These provisions create no direct obligation to measure UV. They do, however, illustrate a broader development: material composition, manufacturing process and possible migration are increasingly considered together in regulation. For UV-curing coatings, varnishes, adhesives and printing inks, reproducible and documented production conditions therefore gain importance. One positive side effect: UV curing works without solvents and as a rule emits no volatile organic compounds, which often keeps installations below the thresholds of the 31st German Federal Immission Control Ordinance – an advantage that increasingly connects with CSRD and taxonomy reporting duties.

The Medical Device Regulation (EU) 2017/745 requires a documented quality management system covering production and product realisation, expressly including production processes, quality assurance and control techniques, in-process inspections, test equipment and its traceable calibration.¹¹ ISO 13485:2016 sets out quality management for medical devices in more detail and attaches particular importance to process validation, especially where the result of a process cannot be fully verified by subsequent inspection or measurement.¹²

UV-curing adhesives are used for catheters, cannulas, syringes, sensors, optical assemblies, microfluidic systems, wearables and diagnostic consumables, among others. Because the quality of an adhesive bond often cannot be fully assessed non-destructively on the finished product, UV curing becomes the classic “special process”: the manufacturer must demonstrate that the process works reproducibly within specified limits, rather than merely confirming that the UV source was switched on. Typical process parameters are wavelength, irradiance, dose, distance, exposure time, temperature and LED ageing.

The economic damage caused by a process failure is very high in this market segment: batch rejection, CAPA procedures, complaints, audit findings and recalls exceed the cost of a radiometer by orders of magnitude.

In-vitro diagnostics

A comparable principle applies to IVD products under Regulation (EU) 2017/746: it explicitly requires control and quality assurance procedures for manufacturing processes and inspections before, during and after manufacture; the test equipment used must be appropriately and traceably calibrated.¹³ UV-curing adhesives and polymers are used in microfluidic cartridges, lab-on-chip systems, biosensors, PCR cartridges and point-of-care systems; bonding, coating and polymerisation are frequently quality-relevant manufacturing steps. Technologically this segment closely resembles medical device manufacturing and can be addressed with the same measurement platform.

Annex 15 of the EU GMP Guide deals explicitly with qualification and validation: manufacturers must determine what qualification and validation work is required to demonstrate control of the critical aspects of their facilities, equipment and processes; changes that affect product quality must be validated.¹⁴ The version in force since October 2015 expressly takes account of the increased importance of modern process validation and the life-cycle approach.

UV applications can form part of production in polymerisation processes, bonding processes, packaging processes, decontamination procedures and in the treatment of ultrapure water (TOC reduction, disinfection of PW/WFI loops). UV is not automatically a GMP-critical process; as soon as the UV treatment performs a critical quality function within the pharmaceutical control strategy, however, validation requirements arise. Of particular interest here is the combination of hardware and software: UV sensor, validatable data acquisition and electronic batch documentation.

A special case is the pathogen inactivation of blood products (for example UVC-based methods without a photoactive substance, or riboflavin-plus-UV methods). From 7 August 2027 the SoHO Regulation (EU) 2024/1938 applies, replacing the previous blood and tissue directives 2002/98/EC and 2004/23/EC and introducing, for the first time, an EU-wide harmonised authorisation procedure for innovative preparations of substances of human origin.²² For UV-based pathogen reduction methods this creates a single harmonised EU authorisation route instead of 27 national ones.

Ballast water treatment provides an instructive example of the limits of type testing. UV systems are structurally at a disadvantage where UV transmission is low and turbidity high: installations on board can struggle to meet the organism limits of IMO regulation D-2 in ports with impaired water quality, because the test criteria of type approval do not fully represent the range of real port conditions.³² In 2024 the IMO therefore issued guidance for operation under “challenging water quality”, which permits treatment to be bypassed temporarily with a subsequent water exchange on the high seas, provided this is properly planned and documented. At the 84th session of the Marine Environment Protection Committee (MEPC 84) in spring 2026, improvements to the certification, maintenance and monitoring of ballast water management systems were agreed.³¹ Port state control assesses not only the installation but the entire management system, including crew procedures, maintenance, documentation and sampling – compliance here is to a considerable extent a matter of documentation and operator practice.

Alongside the sector-specific rules, several technology and data law frameworks act directly on UV systems and their measurement technology.

RoHS – the expiring mercury exemptions

RoHS exemptions 4(a)-I (low-pressure and amalgam lamps) and 4(f)-IV (medium-pressure curing lamps) nominally expire on 24 February 2027 under Annex III of RoHS Directive 2011/65/EU.²³ On behalf of the European Commission, the Oeko-Institut is examining, as part of the assessment package “Pack 29” launched in spring 2026, whether the exemptions should expire, be renewed or be subdivided further; the associated stakeholder consultation ran from late May to early August 2026.²⁴ Under Article 5(5) of the RoHS Directive, an exemption remains valid until the Commission decides, provided a renewal application was submitted in time; and even if an exemption expired, only the placing on the market of new mercury-containing lamps would be affected, while continued operation, spare parts supply and remaining stock for previously installed systems would remain permissible. This is therefore not an abrupt cut-off date but persistent investment uncertainty, which is currently driving the conversion from mercury to LED systems.

Data Act

Regulation (EU) 2023/2854 (Data Act) has applied since 12 September 2025 and expressly covers connected industrial installations and machinery with IoT functionality, together with accompanying maintenance apps, analytics platforms and remote monitoring services. Users can require that data generated by their connected products be transferred free of charge, in machine-readable form and, on request, directly to third parties. For connected products newly placed on the market, the “access by design” obligation applies from 12 September 2026.²⁵ For operators this means that the measurement data of connected UV systems also become accessible to independent service providers.

Machinery Regulation, Cyber Resilience Act, ESPR

Regulation (EU) 2023/1230 on machinery was published on 29 June 2023, fully replaces the previous Machinery Directive 2006/42/EC and applies directly from 20 January 2027.²⁶ For connected UV controls this adds further requirements for safety-related software and interfaces. The Cyber Resilience Act and the Ecodesign for Sustainable Products Regulation (ESPR), with its planned digital product passport, act as further layers of obligation on connected UV systems.

Is there a legal obligation to monitor a UV process continuously by radiometric means?

No general obligation of that kind exists in any of the sectors examined. The monitoring obligation arises indirectly: as soon as a UV process is classified as a critical control point in the HACCP system, as a critical quality parameter in the pharmaceutical control strategy or as a validated special process in the quality management system, the applicable rules require suitable monitoring, limits, corrective actions and documentation. The classification is made by the operator in the hazard or risk analysis – not by the legislator.

Is a UV system a biocidal product and therefore subject to authorisation?

Pure UV irradiation is not covered by the Biocidal Products Regulation (EU) No 528/2012, because its Article 3(1)(a) only covers effects achieved by means other than mere physical or mechanical action. An exception arises if the source generates ozone in situ – for example with unfiltered excimer emitters below 200 nm. The authorisation requirement then applies via the active substance “ozone generated from oxygen in situ”.

Why are operating hours, lamp current or an on-signal not sufficient proof?

Because they do not capture the quantity that matters. The optical output of a UV source is considerably altered by ageing, soiling of the exit window, temperature, distance, shadowing and product speed, without operating hours or lamp current necessarily changing. What is regulatorily robust is the irradiance actually applied, or the UV dose formed from it over time, at the location of the product.

What does “special process” mean in medical device and IVD manufacturing?

It means a process whose result cannot be fully verified on the finished product by subsequent inspection or measurement. ISO 13485:2016 requires validation for such processes: the manufacturer must demonstrate that the process works reproducibly within specified limits. UV curing of adhesive bonds is the standard case of this pattern, because bond quality on the finished product usually cannot be fully assessed non-destructively.

Which quantities belong in the validation of a UV process?

Wavelength or spectrum of the source, irradiance at the location of the product, the UV dose formed from it, exposure time, distance and geometry, temperature and the ageing of the source. Initial characterisation requires a spectrally resolved measurement; for ongoing monitoring a band-limited sensor is sufficient, provided it has been matched against a traceable spectral reference at that specific source.

What changes on 1 January 2027 for UV printing inks?

From that date the provisions of the German Consumer Goods Ordinance for printing inks on food contact articles, as recast by the amending regulation of 19 December 2025, largely apply. Section 4 will explicitly govern monomers, colourants, solvents, additives and photoinitiators; for substances not listed, a non-detection limit of 0.01 mg/kg food applies in the case of indirect food contact. The more strictly residual monomers and photoinitiators are limited, the more important proof of complete cure becomes.

Do the RoHS exemptions for mercury-containing UV lamps expire in February 2027?

Nominally, exemptions 4(a)-I and 4(f)-IV cease to apply on 24 February 2027. Under Article 5(5) of the RoHS Directive, however, an exemption remains valid until the Commission decides, provided a renewal application was submitted in time, and even expiry would only affect the placing on the market of new lamps. Continued operation, spare parts supply and remaining stock of systems already installed would remain permissible. In practice this is therefore not a cut-off date but persistent investment uncertainty.

Why is traceable calibration of the UV sensor required?

Because the rules expressly include the test equipment: the MDR, the IVDR and the EU GMP Guide require that the measuring equipment used for process monitoring be appropriately and traceably calibrated. Without traceability a dose value is not evidence but a reading. In practice this means a documented calibration interval, a known measurement uncertainty and a defined course of action when alarm limits are exceeded.

How can a UV process be documented automatically?

By recording the reading together with its boundary conditions, not just a pass signal. A record only carries weight with irradiance and dose, spectral band, sampling rate, sensor serial number, calibration status and time stamp; a device status to NAMUR NE 107 separates failure, function check, out-of-specification and maintenance required. Digital interfaces such as RS-485 or Modbus TCP transmit these details, an analogue output does not. Without calibration status an archived value is no proof in an audit.

The following sources were used for this report and are referenced in the text by superscript numbers.

1. Regulation (EC) No 852/2004 on the hygiene of foodstuffs, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32004R0852

2. Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32006R2023

3. QMP Jena, “Änderung der Bedarfsgegenständeverordnung” (amendment of 19 December 2025, published in the Federal Law Gazette). https://www.qmp-jena.de/aenderung-der-bedarfsgegenstaendeverordnung/

4. Schulz Flexgroup, “German Ink Ordinance: new requirements for printing inks in food packaging”, June 2026. https://www.schulz-flexgroup.de/2026/06/30/german-ink-ordinance-neue-vorgaben-fuer-druckfarben-in-lebensmittelverpackungen/

5. German Consumer Goods Ordinance (Bedarfsgegenständeverordnung, BedGgstV), Section 4 and Annex 14, Gesetze im Internet. https://www.gesetze-im-internet.de/bedggstv/BedGgstV.pdf

6. CVUA Stuttgart on the EuPIA photoinitiator list: migration threshold of 10 µg/kg or functional barrier. https://cvuas.de/pubmobil/beitrag.asp?Thema_ID=3&ID=3743&subid=1

8. German Federal Ministry for the Environment (BMUV) on the PPWR (EU) 2025/40. https://www.bundesumweltministerium.de/themen/kreislaufwirtschaft/…/europaeisches-recht-ueber-verpackungen-und-verpackungsabfaelle

9. WKO Austria, “PFAS limits in food packaging from August 2026”. https://www.wko.at/gewerbe-handwerk/lebensmittelgewerbe/pfas-grenzwerte-lebensmittelverpackungen

10. Noventiz, “Article 5 of the PPWR: PFAS limits and substance requirements for packaging”. https://www.noventiz.de/artikel-5-der-ppwr-pfas-grenzwerte-und-stoffanforderungen-fuer-verpackungen/

11. Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex. https://eur-lex.europa.eu/eli/reg/2017/745/oj?locale=en

12. Johner Institute, “Process validation: definition and example” on ISO 13485. https://www.johner-institut.de/blog/qualitaetsmanagement-iso-13485/prozessvalidierung/

13. Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR), EUR-Lex. https://eur-lex.europa.eu/eli/reg/2017/746/oj?locale=en

14. European Commission, EU GMP Guide, Annex 15: Qualification and Validation (in force since October 2015). https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf

15. DIN 19294-2:2026-04, Devices for the disinfection of water using ultraviolet radiation – Part 2, DIN Media. https://www.dinmedia.de/de/norm/din-19294-2/397179551

17. DVGW, “UV disinfection in water supply”. https://www.dvgw.de/themen/wasser/wasserwerk-und-aufbereitung/uv-desinfektionsgeraete

18. Commission Implementing Decision (EU) 2024/367 on the European positive lists under Directive (EU) 2020/2184, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400367

19. German Environment Agency (UBA), information on hygienic requirements for materials in contact with drinking water – transitional arrangements. https://www.umweltbundesamt.de/…/uba-information_hygienische_anforderungen_uebergangsregelungen_rev02.pdf

20. German Environment Agency (UBA), FAQ on the Urban Wastewater Treatment Directive. https://www.umweltbundesamt.de/themen/wasser/abwasser/faq-zur-kommunalabwasserrichtlinie-karl

21. Gesundheitsindustrie Baden-Württemberg, “EU Urban Wastewater Treatment Directive: stricter rules and more producer responsibility”. https://www.gesundheitsindustrie-bw.de/fachbeitrag/aktuell/eu-kommunalabwasserrichtlinie-karl

22. Paul Ehrlich Institute on the SoHO Regulation (EU) 2024/1938. https://www.pei.de/…/260515-substanzen-menschlichen-ursprungs-soho.html

23. Opsytec, “RoHS and UV lamps – current regulations and developments”. RoHS and UV lamps

24. Advanced UV, “Major update 2026: RoHS exemptions for UV technologies” (Pack 29, Oeko-Institut). https://www.advanced-uv.de/news/major-update-2026-rohs-ausnahmen-uv-technologien/

25. DIHK, “Data Act: next level as of 12 September 2026”. https://www.dihk.de/en/service-portal/…/data-act-next-level-as-of-12-september-2026

26. IHK Dortmund, “Machinery Regulation (EU) 2023/1230 takes effect in 2027”. https://www.ihk.de/dortmund/…/maschinenverordnung-eu--6797516

27. Commission Implementing Regulation (EU) 2025/89 authorising UV-treated Tenebrio molitor powder as a novel food, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202500089

28. Commission Implementing Regulation (EU) 2022/196 extending the use of UV-treated baker’s yeast, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0196

31. DNV, “IMO MEPC 84: revisiting the Net-Zero Framework”, 2026. https://www.dnv.com/news/2026/imo-mepc-84-revisiting-the-net-zero-framework/

32. Seaclean, “UV-based ballast water treatment systems: mechanism, UVT…”. https://seaclean.no/insights/uv-ballast-water-treatment-systems

33. Directive (EU) 2024/3019 concerning urban wastewater treatment (recast), EUR-Lex. https://eur-lex.europa.eu/eli/dir/2024/3019/oj/eng

34. IHK Karlsruhe, “EU: new Packaging Regulation (PPWR)”. https://www.ihk.de/karlsruhe/…/eu-neue-verpackungsverordnung-ppwr-6958308

35. Videojet, “German printing ink ordinance: checklist for manufacturers”. https://www.videojet.de/de/homepage/resources/learn/german-printing-ink-ordinance-regulation.html

• UV disinfection – reduction-equivalent fluence, type testing to DIN 19294 and biodosimetry.
• Water and environmental technology – UV/H₂O₂ as advanced oxidation and barriers subject to validation in water reuse.
• Plants, agriculture and food technology – UV in food production and the novel food authorisations for UV-treated products.
• Packaging and filling technology – printing inks, migration and food contact GMP at the UV dryer.
• UV bonding, potting and encapsulation – the special process of medical device and IVD manufacturing.
• Pharmaceuticals and photostability – qualification and validation in the GMP environment.
• Guidelines, standards and norms in UV – the measurement standards the regulations refer to.

Do you have to demonstrate for a UV process that it works reproducibly within specified limits – and are you looking for the right measurands, alarm limits and calibration intervals? We characterise your source spectrally in our calibration laboratory, select the appropriate UV sensor for ongoing monitoring and set up dose acquisition so that it fits your batch documentation. Get in touch.

Dr Mark Paravia
Managing Director and Head of the Calibration Laboratory
Opsytec Dr. Gröbel GmbH, Ettlingen, Germany
Tel. +49 (0)7243 / 94 783-50 · mark.paravia@opsytec.de