Instrument sterilization is governed by federal legislation in Belgium. The Royal Decree of 25 November 2005 mandates Class B autoclaves for tattoo artists and piercers. CSS/HGR recommendations define best practices for healthcare professions.
In Belgium, sterilisation requirements vary by profession. Tattoo artists and piercers are subject to the Royal Decree of 25 November 2005 (AR 25/11/2005), one of the strictest regulations in Europe for this sector. Dentists follow the recommendations of the Superior Health Council (CSS/HGR — opinions 8363 and 9682) and INAMI convention obligations. Podiatrists, a recognised paramedical profession since the Royal Decree of 2 July 2009, follow CSS/HGR 9682 recommendations. Permanent makeup (dermopigmentation) practitioners fall under CSS recommendation 8719, which is not legally binding.
The principle is the same across all professions: any instrument that penetrates the skin barrier or comes into contact with mucous membranes should either be single-use and sterile, or sterilised in an autoclave before each use.
Standard EN 13060 defines the requirements for small steam sterilisers used in clinics and studios. It distinguishes three autoclave classes: N (solid, unwrapped instruments), S (specific cycles defined by the manufacturer), and B (the most versatile — hollow instruments, wrapped loads, textiles). The Royal Decree of 25/11/2005 specifically requires Class B for tattoo and piercing studios in Belgium.
The autoclave must undergo regular validation: daily Bowie-Dick or Helix test before the first load, and regular biological controls (spore indicators). For more details, see the autoclave classes guide.
The FPS Public Health (SPF Santé publique, Sécurité de la Chaîne alimentaire et Environnement) is the federal authority responsible for the agrément (ministerial approval) of tattoo and piercing studios. It can conduct inspections and impose sanctions for non-compliance.
The Superior Health Council (CSS/HGR) is the scientific advisory body that issues sterilisation recommendations for all health professions. Its opinions (8363 for dental, 8719 for permanent makeup, 9682 for medical device sterilisation) are the benchmark.
INAMI/RIZIV manages conventions with healthcare providers. For dentists and podiatrists, compliance with sterilisation best practices is part of their convention obligations.
The AFSCA (Federal Agency for the Safety of the Food Chain) may also participate in inspections of tattoo and piercing studios.
During a tattoo or piercing studio inspection, inspectors verify: ministerial agrément (mandatory under AR 25/11/2005), the 20-hour hygiene training certificate, autoclave compliance (Class B required), cycle traceability (complete register with date, parameters, result), process and biological indicators, use-by dates on pouches, medical waste management, and that the sterilisation room follows the one-way workflow (marche en avant).
For dental practices, inspections cover the same technical elements, plus INAMI convention requirements and CSS/HGR 8363 recommendations.
For tattoo artists and piercers: the AR 25/11/2005 provides severe penalties. Sentences range from 8 days to 3 years of imprisonment and/or fines from €160 to €4,000,000. Failure to hold the required agrément, training certificate, or sterilisation compliance can result in studio closure.
For dentists: disciplinary sanctions from the Conseil de l'Art Dentaire, consequences on INAMI reimbursements, criminal prosecution in case of patient harm.
For podiatrists: sanctions related to professional agrément (community-level), consequences on INAMI reimbursements.
For PMU practitioners: no specific penalties (CSS 8719 is not legally binding). General civil and criminal liability applies in case of harm to the client.
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