Tag: SCCS

  • The 4.2% That Decides Whether Your Nano-Hydroxyapatite Is Legal in Europe

    The 4.2% That Decides Whether Your Nano-Hydroxyapatite Is Legal in Europe

    The dossier is nearly finished. The formulation is locked, the claims are drafted, and the toothpaste is scheduled for three EU markets. Then the regulatory reviewer asks for one document the supplier has never been asked to produce: the particle aspect-ratio distribution, counted, with percentages.

    What exactly did the SCCS approve?

    In March 2023, the EU’s Scientific Committee on Consumer Safety adopted its final opinion on hydroxyapatite (nano) — SCCS/1648/22 — and the numbers in it are precise. The committee “considers hydroxyapatite (nano) safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.” That is the sentence suppliers quote. The sentence that decides whether the opinion applies to your drum comes earlier: the material must be “composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9.”

    Two more exclusions close the perimeter. “This Opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles.” And it is “not applicable to sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.” Breath sprays are out. Needles are out. Coated or surface-modified grades were never assessed.

    Notice what kind of rule this is. It does not grade materials from better to worse; it draws a boundary around one tested particle population and stays silent about everything outside it. Silence is not approval. A grade that is 94% below aspect ratio 3 is not “slightly less compliant” — it is simply not the material the opinion assessed, and a safety case built on the opinion no longer applies to it. Regulators read specifications the way auditors read contracts: the perimeter is the promise, and the promise is only as good as the measurement behind it.

    Why “rod-shaped” on a datasheet is not compliance

    Read the specification again as a measurement task. It is not a shape adjective; it is a number-weighted distribution with a threshold at an aspect ratio of 3 and a hard ceiling at 4.9, established by counting particles in electron micrographs. A datasheet that says “rod-shaped nano-hydroxyapatite” asserts a category. The opinion demands a census.

    The history explains the strictness. In its earlier assessments the committee “stressed that the available data/information was not sufficient to exclude concerns over the genotoxic potential” of the material — concerns it resolved in the final opinion only for the exact particle population described above. The safety conclusion and the shape distribution are not two paragraphs of the same document. They are one finding.

    The question to send your supplier

    So the compliance question is not “is your material nano-hydroxyapatite?” It is: what fraction of particles, by number, sits below an aspect ratio of 3 — and does any particle in the tail exceed 4.9? A supplier who runs that count on every lot can answer with a distribution and a micrograph. A supplier who has never been asked will answer with the datasheet adjective, and the gap between those two answers is the difference between an ingredient you can defend in front of a European reviewer and one you cannot.

    Shape, in this market, is not a morphology detail. It is the legal identity of the product — and like every identity, it has to be verified per lot, not asserted per brochure.

    Sources

    Scientific Committee on Consumer Safety. “Opinion on Hydroxyapatite (nano), SCCS/1648/22, Final Opinion,” adopted 21–22 March 2023 (open access) — health.ec.europa.eu/system/files/2023-03/sccs_o_269.pdf.

  • Nano-Hydroxyapatite Safety: The EU SCCS Opinion and What Brands Need to Know

    Nano-Hydroxyapatite Safety: The EU SCCS Opinion and What Brands Need to Know

    Nano-Hydroxyapatite Safety: The EU SCCS Opinion and What Brands Need to Know

    Nano-hydroxyapatite is central to many of hydroxyapatite’s benefits in oral and skin care, the small particle size is part of why it interacts so effectively with enamel. But “nano” also triggers specific regulatory scrutiny, particularly in the European Union. For brands, understanding how the EU’s Scientific Committee on Consumer Safety (SCCS) approaches nano-hydroxyapatite is essential. This is an informational overview, not regulatory advice, and brands must check the current, applicable opinion before relying on any summary.

    Why Nanomaterials Get Special Attention

    EU cosmetic regulation treats nanomaterials as a distinct category with their own definitions, notification duties, and safety-assessment expectations. The logic is that particle size can influence how a material behaves and is handled, so regulators ask for nano-specific characterisation and safety data rather than assuming the bulk material’s profile carries over unchanged. Hydroxyapatite is widely used and well studied, but its nano form is assessed on nano-specific terms.

    What the SCCS Has Examined

    The SCCS provides scientific opinions that inform EU regulatory decisions, and it has assessed nano-hydroxyapatite for use in cosmetic products. Broadly, such assessments focus on:

    • Particle characteristics: size, shape (including aspect ratio), and whether particles are present in needle-like or other specific morphologies, details that the committee weighs carefully.
    • Product type and exposure route: leave-on versus rinse-off, and especially whether a product could be inhaled, sprayable and aerosolised formats raise particular concern because of the inhalation route.
    • Concentration and conditions of use under which the material is considered safe.

    The practical upshot is that approval is typically conditional: safe under defined particle characteristics, product types, and uses, rather than a blanket clearance. The morphology and the avoidance of inhalable applications are recurring themes.

    What This Means for Brands

    • Know your particles precisely. You must be able to document size and morphology, because the conditions of use hinge on them. Vague “nano-HAp” claims will not satisfy a dossier.
    • Match format to the guidance. Sprayable or otherwise inhalable products demand particular caution given the inhalation-route concerns.
    • Track the current opinion. SCCS opinions and the regulatory measures that follow can evolve; rely on the latest text, not a remembered summary.
    • Lean on supplier data. A grade with thorough, consistent particle characterisation makes a compliant safety dossier far easier to assemble.

    How Ingredient Quality Supports Compliance

    Much of what the SCCS scrutinises, particle size, morphology, purity, is exactly what a well-engineered grade controls and documents. When a supplier can demonstrate consistent, well-characterised particles, brands can map their material confidently against the conditions of use. Hydroxyapatite-LC by BiST Tech Japan is referenced as a benchmark partly because controlled crystal structure and characterisation provide the kind of documentation that regulatory work depends on. For broader context on classifications across markets, see our overview of hydroxyapatite regulatory status, and our oral care section.

    This article is for educational purposes only and is not legal or regulatory advice. The regulatory status of nanomaterials evolves; always consult the current SCCS opinion, applicable EU regulation, and a qualified regulatory professional before marketing a nano-hydroxyapatite product.