CLP Regulation Annex II. Section 3.4.
When hazardous substances or mixtures are supplied via refill stations, suppliers must meet the following conditions:
1. Labeling Compliance:
- Each refill station must carry labels corresponding to the hazardous substances or mixtures it dispenses.
- Labels must be firmly affixed horizontally in a visible place and comply with Article 31(2), (3), and (4).
- If multiple substances or mixtures share the same label elements (e.g., hazard pictograms and signal words), a single label may be used, provided each substance or mixture is clearly named.
- Risk Mitigation Measures:
- Measures must be in place to minimize exposure risks to humans (especially children) and the environment.
- Access to refill stations must be controlled to prevent use by children or unauthorized persons.
- Suppliers must ensure that refilled substances or mixtures do not react dangerously with each other.
- Supplier Responsibilities:
- At the moment of refill, a supplier must be available on-site to provide maintenance and emergency assistance.
- Refill stations operated outdoors or outside business hours must have immediate assistance available.
- Employees must be trained to minimize safety risks to consumers and professional users.
2. Packaging and Labelling of Refilled Containers
- Each refilled package must comply with:
- Hazard communication requirements (Title III of the CLP Regulation).
- Packaging requirements (Title IV of the CLP Regulation).
- If small containers are used (≤10mL), specific exemptions for label elements may apply.
3. Prohibited Hazardous Substances for Refill Stations
CLP Regulation Annex II. Section 3.4.
Hazardous substances or mixtures cannot be provided at refill stations if they fall under any of the following classifications:
- Health Hazards:
- Acute toxicity (any category).
- Specific target organ toxicity (single or repeated exposure).
- Skin corrosion (Category 1).
- Serious eye damage (Category 1).
- Respiratory or skin sensitization.
- Aspiration hazard.
- Germ cell mutagenicity.
- Carcinogenicity.
- Reproductive toxicity.
- Endocrine disruption (for human health or the environment).
- Physical and Environmental Hazards:
- Flammable gases, liquids (Category 1 & 2), and solids.
- Persistent, bioaccumulative, and toxic (PBT) substances.
- Very persistent and very bioaccumulative (vPvB) substances.
- Persistent, mobile, and toxic (PMT) substances.
- Very persistent and very mobile (vPvM) substances.
Label Size Requirements and Exemptions for Refill Stations
1. Minimum Label Dimensions and Font Size for Refill Stations
Labels at refill stations must adhere to general CLP labeling dimensions. The minimum label and pictogram sizes depend on the volume of the packaging:
| Capacity of the Package | Minimum Label Dimensions (mm) | Minimum Pictogram Size (mm) | Minimum Font Size (x-height, mm) |
| ≤ 0.5 L | At least 52 × 74 (if possible) | At least 10 × 10 (if possible 16 × 16) | 1.2 mm |
| > 0.5 L to 3 L | At least 74 × 105 | At least 23 × 23 | 1.4 mm |
| > 3 L to 50 L | At least 105 × 148 | At least 32 × 32 | 1.8 mm |
| > 50 L to 500 L | At least 148 × 210 | At least 46 × 46 | 2.0 mm |
| > 500 L | At least 148 × 210 | At least 46 × 46 | 2.0 mm |
For inner packaging not exceeding 10 mL, the font size may be smaller, provided that it remains legible and the most critical information (such as hazard statements) is included.
2. Labeling Exemptions for Refill Stations
Special exemptions apply to refill stations, allowing for certain flexibilities:
- Single Label for Multiple Substances:
- If multiple substances or mixtures have identical label elements (e.g., same hazard pictograms and signal words), a single label may be used for the refill station instead of separate labels for each substance.
- The label must still clearly indicate the name of each applicable substance or mixture.
- Exemptions for Small Inner Packaging (≤10 mL):
- If the inner packaging is ≤10 mL, certain label elements (except essential hazard statements) may be omitted if the outer packaging meets full labeling requirements.
- Digital Labeling Option:
- Some non-essential label elements may be provided digitally, provided that users are informed via a data carrier (QR code, barcode, etc.).
- If a digital label is unavailable at the time of refill, the supplier must provide the required information in an alternative format, free of charge.
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