REACH Compliance: What Fragrance Importers Must Document

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals, Regulation EC 1907/2006) is the EU’s primary chemical safety regulation. For fragrance importers bringing products into the EEA from non-EU manufacturers, REACH creates direct legal obligations that cannot be delegated upstream. Understanding what to document, and when, is essential to avoid customs holds, market surveillance actions, and penalties.

Who Bears the Obligation?

Under REACH Article 3(11), any natural or legal person established in the EU who imports a substance on its own, in a mixture, or in an article is the “importer” and bears registration and communication duties. This means:

• A European distributor importing finished perfume from Asia is the REACH importer.
• A non-EU manufacturer (e.g., a Chinese fragrance factory) has no direct REACH obligations but must supply data to enable the EU importer’s compliance.
• An Only Representative (OR) appointed under Article 8 can assume the non-EU manufacturer’s registration duties, relieving individual importers.

If you import more than 1 tonne per year of any substance (calculated across all products), registration with ECHA is mandatory unless an exemption applies.

Registration Thresholds and Timelines

Annual Volume	Registration Requirement
Below 1 tonne/year	No registration required
1-10 tonnes/year	Registration with basic physicochemical and toxicological data
10-100 tonnes/year	Full registration with extended testing
Above 100 tonnes/year	Full registration with chemical safety report (CSR)

For fragrance products, the relevant substances are typically individual aroma chemicals (e.g., linalool CAS 78-70-6, limonene CAS 5989-27-5, vanillin CAS 121-33-5). The tonnage is calculated per substance across all imported mixtures.

Most common fragrance raw materials were pre-registered and are now fully registered. Importers should verify registration status via the ECHA database and obtain the registration number from their supplier.

SVHC Screening: The Candidate List Obligation

The REACH Candidate List of Substances of Very High Concern (SVHC) is updated twice yearly (June and December). As of early 2025, it contains over 240 substances. For fragrance products, relevant SVHCs include:

• Certain phthalates (DEHP, DBP, BBP, DIBP) used historically as fixatives
• Specific musk compounds under review for PBT properties
• Formaldehyde-releasing preservatives in some formulations

Importer duties regarding SVHCs:

1. Article 33 (Information duty): If a product contains an SVHC above 0.1% w/w, the importer must provide sufficient information to allow safe use, including the substance name, to recipients and (upon request within 45 days) to consumers.

2. Article 7(2) (SCIP notification): Articles containing SVHCs above 0.1% must be notified to ECHA via the SCIP database. This primarily affects packaging components (e.g., certain plasticizers in caps or labels).

3. Annex XIV (Authorisation): If an SVHC is listed in Annex XIV, it cannot be used after the sunset date without an authorisation. Currently, no core fragrance ingredients are on Annex XIV, but importers should monitor proposed entries.

Safety Data Sheets: The 16-Section Standard

Under REACH Article 31, an SDS must be provided for any substance or mixture classified as hazardous under CLP, or containing an SVHC above 0.1%. The SDS must follow the 16-section format specified in Annex II:

1. Identification
2. Hazard identification
3. Composition/information on ingredients
4. First-aid measures
5. Fire-fighting measures
6. Accidental release measures
7. Handling and storage
8. Exposure controls/personal protection
9. Physical and chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information
15. Regulatory information
16. Other information

Key documentation points for fragrance importers:

• Section 3 must disclose all ingredients classified under CLP at or above their generic concentration limits, plus any substance with an EU occupational exposure limit.
• Section 15 must list REACH registration numbers, authorisation numbers (if applicable), and any national restrictions.
• The SDS must be provided in the official language of the member state where the product is placed on the market.
• Updated SDS must be issued without delay when new hazard information becomes available or an authorisation is granted/refused.

Restrictions Under Annex XVII

Annex XVII of REACH lists specific use restrictions. For fragrance products, relevant entries include:

• Entry 43 (Azo dyes): Restrictions on colorants in textile/leather components of packaging.
• Entry 68 (PFOA): Limits perfluorooctanoic acid, relevant to some coating treatments on packaging.
• Entry 77 (Formaldehyde): Maximum 75 mg/kg in finished articles in direct skin contact.

Importers should maintain a compliance matrix mapping each product SKU against applicable Annex XVII entries.

Documentation Retention

REACH does not prescribe a single retention period, but member state enforcement authorities typically expect records for 10 years after the last supply. Essential documents include:

• Supplier SDS and extended SDS (eSDS) with exposure scenarios
• Registration numbers and tonnage calculations
• SVHC screening records (dated, with Candidate List version referenced)
• Test reports supporting classification
• Communication records with downstream users
• Only Representative appointment letters (if applicable)

How Aromiso Supports REACH Documentation

Aromiso provides EU importers with a complete REACH documentation package:

• Full 16-section SDS in English and 23 additional EU languages
• Allergen declarations with CAS numbers and concentration ranges
• SVHC screening statements updated within 30 days of each Candidate List revision
• REACH registration numbers for all registered substances in our formulations
• Composition disclosure sufficient for importer tonnage calculations (under NDA where required)

Our regulatory team monitors ECHA updates, RAC/SEAC opinions, and proposed Annex XVII amendments to flag changes that affect your product portfolio before they become enforceable.

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REACH obligations are complex and fact-specific. This article provides a general framework; consult a qualified regulatory affairs specialist for product-specific compliance decisions.