NANOMATERIALS AND REACH/CLP COMPLIANCE

Substances may exist in both nanoform and non-nanoform. A single REACH registration can cover multiple nanoforms while sharing the same substance identity. Nanoforms may differ in key parameters such as:

• Particle size distribution
• Particle shape and aggregation state
• Surface chemisty and functionalization

For substances manufactured or imported as nanoforms, REACH requires a detailed nanoform composition record within the registration dossier. Different nanoforms of a substance must be characterized separately, ensuring that their physicochemical properties, hazard profiles, and exposure risks are properly evaluated.

REACH obligations for nanomaterials include

Nanoform identification & registration – Proper documentation of each nanoform in IUCLID.
Toxicological & environmental safety assessments – Nano-specific hazards are addressed.
Safety Data Sheets (SDS) for nanoforms – Inclusion of nanoform information, hazards and recommended risk management measures.
Grouping & read-across strategies – Scientifically justified read-across or alternative methods to reduce testing costs.

CLP classification & labeling for nanoforms

Hazard classification – Proper classification for inhalation toxicity, persistence, and reactivity.
Labeling of nano-containing products – Nano-specific labeling where applicable.
Carcinogenicity & inhalation risks – Specific labeling for suspected carcinogenic effects (Category 2, inhalation hazard).
Worker safety & occupational exposure – Specific precautionary statements and exposure control recommendations in SDSs.

Our team has extensive experience in nanoform characterization, risk assessment, dossier preparation, hazard classification, and labeling ensuring that your nanomaterials meet REACH and CLP requirements.

 

SECTOR-SPECIFIC COMPLIANCE OF NANOMATERIALS

Nanomaterials in biocidal products

Biocidal products containing nanomaterials require specific safety and efficacy evaluations under the Biocidal Products Regulation (BPR). If a nanoform is not explicitly approved as part of an active substance, its use in biocidal formulations is not permitted.

Nanomaterials require a separate risk assessment under BPR, as their properties may differ from bulk materials. They are also not eligible for simplified authorization under BPR Article 25. Instead, companies must provide:

Nanoform-specific risk assessments – Addressing potential risks to human health (e.g., inhalation, dermal absorption), animal health (e.g., bioaccumulation), and environmental fate (e.g., persistence, mobility).
Validated test methods – Justifying the scientific suitability of biocidal efficacy tests for nanomaterials and necessary modifications.
Labeling & consumer information – All nanomaterials must be explicitly listed on product labels, followed by ‘nano’ in brackets. Any identified risks must be clearly disclosed.

We provide expert support in testing strategies, risk assessment, dossier preparation, and regulatory compliance, ensuring your biocidal products meet BPR requirements efficiently.

Nanomaterials in electronics & energy

We assist battery manufacturers, electronic component developers, and material suppliers.  Key applications requiring regulatory compliance include:

Silicon-based nanomaterials to enhance lithium-ion battery performance with higher energy density and faster charging (REACH/CLP, Battery Regulation (EU 2023/1542)).
Graphene-based conductive inks used in flexible circuits, touch sensors, and advanced wearables (REACH/CLP, RoHS).
Nanostructured catalysts (Pt, Pd, Au) to improve hydrogen fuel cells and automotive emission reduction  (REACH/CLP, Industrial Emission Directive).

Nanomaterials in coatings & materials science

We support automotive manufacturers, construction coatings developers, and consumer product companies. Key applications include:

Nano-Titanium dioxide (TiO₂) used in self-cleaning glass, antimicrobial coatings, and UV-protective materials. Due to inhalation toxicity and environmental exposure concerns, compliance is required under REACH/CLP and BPR (if antimicrobial function claimed).
Carbon nanotube & graphene-enhanced composites used in aerospace, automotive, and lightweight high-strength materials (REACH/CLP, Worker Safety (EU Directives 98/24/EC & 2004/37/EC)).
Nanoclay-Enhanced packaging improves food preservation by preventing spoilage and contamination (REACH/CLP, Food Contact Materials Regulation (EC 1935/2004)).

Nanomaterials in environmental & agricultural applications

We provide testing, regulatory consulting, and risk assessment services for nano-enabled agrochemicals. Key areas requiring regulatory compliance include:

Nano-based water purification (TiO₂, CNTs, MOFs) used in filtration membranes, photocatalysis, and antimicrobial water treatment (REACH/CLP, BPR if antimicrobial action in purification, Drinking Water Directive (EU 2020/2184)).
Nano-encapsulated pesticides & fertilizers used to enhance the efficiency and controlled release of agrochemicals, reducing runoff and environmental impact (REACH/CLP, Fertilizer Products Regulation (EU 2019/1009)).

 

Need assistance with nanomaterials compliance and registration? Contact us today to streamline your regulatory process.