Complete Guide to SDS Authoring: REACH Requirements for Section 15 of SDS
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In chemical safety compliance, SDS authoring presents unique challenges, especially when it comes to Section 15 of SDS. This comprehensive guide details the explicit REACH regulatory requirements for Section 15 of SDS and provides practical guidance for ensuring compliance.
REACH Requirements for Section 15 of SDS
According to REACH Regulation (EC) No 1907/2006, as amended by Regulation (EU) 2020/878, Section 15 of SDS must contain specific information about safety, health, and environmental regulations applicable to the substance or mixture. Proper SDS authoring ensures this section complies with all legal requirements.
Structure of Section 15 Under REACH
Section 15 of SDS is divided into two mandatory subsections:
15.1: Safety, health and environmental regulations/legislation
15.2: Chemical safety assessment
Each subsection has specific content requirements for compliant SDS authoring.
15.1: Required Regulatory Information
When performing SDS authoring for Section 15 of SDS, the following EU regulations must be addressed:
REACH-Specific Information Requirements
1. REACH Annex XVII Restrictions
SDS authoring for Section 15 of SDS must include:
Clear indication if any substance in the mixture is subject to restrictions
Entry numbers and specific conditions if restrictions apply
Statement if no restrictions apply (e.g., "Contains no substances subject to restrictions according to REACH Annex XVII")
2. REACH Annex XIV Authorizations
Complete SDS authoring for Section 15 of SDS requires:
List of any substances requiring authorization under REACH
Authorization numbers if applicable
Statement if no authorizations apply (e.g., "Contains no substances listed on REACH Annex XIV (Authorisation List)")
3. REACH Candidate List (SVHC)
Thorough SDS authoring must address:
Identification of any Substances of Very High Concern present
Concentration information if SVHCs exceed 0.1% w/w
Statement if no SVHCs are present (e.g., "Contains no substances on the REACH Candidate List")
Other Required EU Regulations for Section 15
Comprehensive SDS authoring for Section 15 of SDS must also address:
1. PIC Regulation (Prior Informed Consent)
Regulation (EU) 649/2012
Statement whether substances are subject to export/import notification
2. POP Regulation (Persistent Organic Pollutants)
Regulation (EU) 2019/1021
Statement whether substances are subject to restrictions for persistent organic pollutants
3. Ozone Depleting Substances
Regulation (EU) XXXX/XXX (current version)
Statement whether substances deplete the ozone layer
4. Biocidal Products Regulation
Regulation (EU) No 528/2012
Active substance information and authorization details if applicable
5. Plant Protection Products
Regulation (EC) No 1107/2009
Statement if active substances are present
6. Seveso Directive
Directive 2012/18/EU
Hazard categories and named substances if applicable
7. Volatile Organic Compounds (VOC)
Directive 2004/42/EC
VOC content information if applicable
8. Explosives Precursors
Regulation (EU) 2019/1148
Statement if restricted precursors are present
9. Drug Precursors
Regulation (EC) 273/2004
Statement if precursors are present
National Regulations in Section 15
Compliant SDS authoring for Section 15 of SDS must include relevant national regulations for member states where the product is marketed:
1. Water Hazard Classifications
Germany: WGK classification
Other member state equivalents
2. National Exposure Limits
Country-specific workplace exposure limits
Reference to national legislation
3. National Waste Regulations
Country-specific waste handling requirements
Reference to relevant national legislation
15.2: Chemical Safety Assessment
For compliant SDS authoring, Section 15.2 of SDS requires:
Clear statement whether a Chemical Safety Assessment (CSA) has been performed
If a CSA was performed for specific substances in a mixture, list those substances
Simple, direct statement (e.g., "No chemical safety assessment has been carried out")
When is a Chemical Safety Assessment Required?
A Chemical Safety Assessment (CSA) is mandatory under REACH for:
Substances manufactured or imported at ≥10 tonnes per year per registrant
All substances subject to authorization (regardless of tonnage)
Substances of Very High Concern (SVHCs) in articles above 0.1% w/w and totaling over 1 tonne per year
CSAs are typically not required for:
Substances manufactured/imported below 10 tonnes per year
Substances exempt from registration (e.g., certain polymers, certain intermediates)
Substances in Annex IV or V of REACH (deemed to cause minimum risk)
Substances in mixtures below specified concentration limits
Chemical Safety Report (CSR) Process
The Chemical Safety Assessment results in a Chemical Safety Report (CSR) with the following key elements:
Human Health Hazard Assessment
Evaluation of available toxicological data
Determination of DNEL (Derived No-Effect Level) values
Physicochemical Hazard Assessment
Evaluation of explosive, flammable, and oxidizing properties
Assessment of other relevant physicochemical properties
Environmental Hazard Assessment
Evaluation of ecotoxicological data
Determination of PNEC (Predicted No-Effect Concentration) values
PBT/vPvB Assessment
Evaluation against Persistent, Bioaccumulative and Toxic criteria
Evaluation against very Persistent and very Bioaccumulative criteria
Exposure Assessment
Development of exposure scenarios for all identified uses
Estimation of exposure for each scenario
Risk Characterization
Comparison of exposure with DNEL/PNEC values
Demonstration of risk control for each exposure scenario
Impact on SDS Section 15.2
When documenting Section 15.2 of SDS, the following information should be provided:
For substances that require a CSA:
A chemical safety assessment has been carried out for this substance.
For mixtures where some components require a CSA:
A chemical safety assessment has been carried out for the following components of this mixture: [substance names].
For substances/mixtures not requiring a CSA:
No chemical safety assessment has been carried out for this substance/mixture.
For registered substances where the CSA covers certain uses only:
A chemical safety assessment has been carried out for this substance. Not all exposure scenarios are included in this SDS.
Real-World Example: Section 15 for a Two-Component Mixture
To illustrate proper SDS authoring for Section 15, here's a realistic example of a two-component solvent mixture and how to properly document its regulatory status.
Example Mixture Composition:
Component A: Toluene (CAS: 108-88-3) at 85%
Component B: Methanol (CAS: 67-56-1) at 15%
Sample Section 15 Content for This Mixture:
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU-Regulations
REACH Annex XVII (Restriction List)
Contains substance(s) subject to restrictions according to REACH Annex XVII:
- Toluene (CAS 108-88-3): Entry 48
Shall not be placed on the market or used as a substance or in mixtures in a concentration ≥ 0.1% where the mixture is used in adhesives or spray paints intended for supply to the general public.
- Methanol (CAS 67-56-1): Entry 69
Shall not be placed on the market to the general public after 9 May 2019 in windscreen washing or defrosting fluids in concentrations ≥ 0.6% by weight.
REACH Annex XIV (Authorisation List)
Contains no substances listed on REACH Annex XIV (Authorisation List)
REACH Candidate List (SVHC)
Contains no substances on the REACH Candidate List
PIC Regulation (Prior Informed Consent)
Contains no substances subject to Regulation (EU) 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals.
POP Regulation (Persistent Organic Pollutants)
Contains no substances subject to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants.
Ozone Regulation
Contains no substances subject to Regulation (EU) 2024/590 of the European Parliament and of the Council on substances that deplete the ozone layer.
Seveso Directive (2012/18/EU)
P5c FLAMMABLE LIQUIDS
E2 Hazardous to the Aquatic Environment in Category Chronic 2
VOC Directive (2004/42/EC)
VOC content: 100% (1000 g/L)
Explosives Precursors Regulation (EU 2019/1148)
Contains methanol (CAS 67-56-1) - Precursor subject to reporting of suspicious transactions
National regulations
Germany
Water hazard class (WGK): 2, Significantly hazardous to water (Classification according to AwSV, Annex 1)
Employment restrictions: Observe restrictions according Technical Rules for Hazardous Substances (TRGS) 401, 402, 500, 510, 800
Storage class (LGK): 3 (Flammable liquids)
Netherlands
SZW-lijst van kankerverwekkende stoffen: None of the components are listed
SZW-lijst van mutagene stoffen: None of the components are listed
SZW-lijst van reprotoxische stoffen: Toluene is listed
France
Occupational diseases: RG 4bis (Methanol), RG 84 (Toluene)
15.2. Chemical safety assessment
A chemical safety assessment has been carried out for the substances in this mixture.
The relevant exposure scenarios are attached to this Safety Data Sheet.Explanation of Regulatory Entries
REACH Annex XVII: Both components are subject to restrictions:
Toluene (Entry 48): Restricted in adhesives and spray paints for public
Methanol (Entry 69): Restricted in windscreen washing fluids
Seveso Directive: The mixture qualifies under two Seveso categories:
P5c due to its flammable properties (flash point below 60°C)
E2 due to toluene's aquatic chronic toxicity
VOC Content: Both components are VOCs, resulting in 100% VOC content.
Explosives Precursors: Methanol is listed in Annex II of the Explosives Precursors Regulation, requiring reporting of suspicious transactions.
National Regulations:
German water hazard class (WGK 2) is determined by toluene's WGK classification
Dutch SZW list includes toluene as reprotoxic
French occupational disease tables include both components
Chemical Safety Assessment: Both substances have tonnage bands requiring CSAs under REACH.
Critical Compliance Aspects Often Overlooked in Section 15
When authoring Section 15 of SDS, several critical aspects are frequently overlooked but are essential for regulatory compliance:
1. Duty to Update After Regulatory Changes
REACH Article 31(9) requires suppliers to update SDSs "without delay" when:
New hazard information or information affecting risk management becomes available
An authorization is granted or refused
A restriction is imposed
Important: "Without delay" has been interpreted by enforcement authorities to mean within one month of the regulatory change. Failing to update Section 15 of SDS promptly after regulatory changes can result in enforcement action.
2. Supply Chain Communication Requirements
When a Chemical Safety Assessment has been performed and exposure scenarios developed:
The relevant exposure scenarios must be attached to the SDS
Any downstream user operating outside the conditions described in these exposure scenarios must develop their own CSR or adapt their use to comply
Failure to communicate exposure scenarios to downstream users is a common compliance gap in Section 15 of SDS authoring.
3. Multi-Regional Compliance Requirements
For products marketed in multiple countries, Section 15 of SDS must comply with each country's specific requirements:
Different EU member states may have different national regulations
A single SDS may need multiple country-specific versions of Section 15
Translations must be legally accurate in each language
Enforcement authorities increasingly check for country-specific information in Section 15 of SDS, making this a high-risk area for compliance failures.
4. Duty to Retain SDS Documentation
Under REACH Article 36, companies must:
Keep all information used to prepare the SDS for at least 10 years
Make this information available to authorities upon request
This includes regulatory status determinations documented in Section 15 of SDS, making proper record-keeping of regulatory decision-making essential.
Common Errors in Section 15 SDS Authoring
When creating Section 15 of SDS, avoid these common mistakes:
1. Missing Regulatory Categories
Every required regulatory category must be addressed
"Not applicable" statements are better than omissions
2. Outdated Regulatory References
Current regulation names and numbers must be used
Reference the latest amendments
3. Overly Generic Statements
Specific regulatory status of substances should be addressed
Generic templates without substance-specific information are insufficient
4. Insufficient National Information
Member state-specific information must be included
Generic statements about national regulations are inadequate
Best Practices for Section 15 SDS Authoring
1. Regular Updates
Review Section 15 of SDS whenever regulations change
Establish a systematic update schedule (minimum quarterly)
2. Verification Process
Check each substance against current regulatory lists
Verify concentration thresholds for regulatory applicability
3. Documentation
Document regulatory information sources
Maintain records of which regulatory versions were used
Maintaining Current Regulatory Information
Effective SDS authoring for Section 15 of SDS requires specific approaches to stay current:
Official Publication Monitoring:
Regular review of the Official Journal of the European Union for regulation updates
Subscribing to ECHA's newsletter for announcements on REACH and CLP updates
Following national authority publications for country-specific regulations
Documentation Methods:
Creating revision logs that reference specific regulatory changes
Maintaining dated copies of regulatory texts used for SDS authoring
Recording specific regulation versions used for each Section 15 of SDS
Update Procedures:
Establishing a regular schedule (quarterly at minimum) to review Section 15 of SDS content
Implementing a systematic process to check each substance against updated regulations
Developing clear criteria for when an SDS revision is required based on regulatory changes
Conclusion: Expert SDS Authoring for Compliant Safety Documentation
Navigating the detailed requirements for Section 15 of SDS under REACH regulations requires expertise and attention to detail. Our professional SDS authoring services ensure your safety documentation is fully compliant with all current regulatory requirements.
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Verification of all required regulatory categories in your SDS
Assessment of REACH Annex XVII, XIV and SVHC references
Validation of Chemical Safety Assessment statements
Check for country-specific national regulations
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Related Regulatory Resources for SDS Authoring
For comprehensive SDS compliance, familiarize yourself with these related regulations:
CLP Regulation - Learn about classification, labeling, and packaging requirements under Regulation (EC) No 1272/2008, which works alongside REACH to ensure chemical safety.
REACH Regulation Overview - Understand the full scope of Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) requirements for substance registration and safety.
SDS Format Guidelines - Explore the required 16-section format for Safety Data Sheets according to REACH Annex II.
Exposure Scenarios for SDS - Guidance on creating and attaching exposure scenarios required for substances registered at ≥10 tonnes per year.
These complementary resources will help you develop a complete understanding of the regulatory framework for chemical safety communication in the EU.