What Is the REACH Regulation and Why It Is Key
Regulation (EC) No 1907/2006, known as REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), is the legal framework governing the manufacture, placing on the market, and use of chemical substances within the European Union.
Its main objective is to ensure a high level of protection of human health and the environment, while shifting the responsibility for demonstrating safety onto industry. This represents a significant change from previous regulatory approaches, as companies must generate data, justify uses, and keep information updated over time.
In practice, REACH is not just a regulation, but a comprehensive system for chemical risk management that affects multiple sectors, including cosmetics.
Scope of the REACH Regulation
REACH applies to a wide range of situations, which explains its broad industrial impact. It covers substances on their own, substances in mixtures, and, in certain cases, substances contained in articles.
In general terms, it applies to:
- Substances on their own.
- Chemical components within mixtures.
- Certain substances present in articles.
This includes everything from industrial raw materials to ingredients used in consumer products.
However, there are specific exemptions, such as substances regulated under other frameworks (e.g. medicines, food, waste). Even so, these exemptions do not remove the need for safety assessment, but rather shift it to other regulatory systems.
The Four Pillars of REACH
The Regulation is structured around four main mechanisms that allow control of chemical risks throughout their lifecycle.
Registration
Registration is the entry point into the REACH system. Any substance manufactured or imported in quantities of one tonne or more per year must be registered with ECHA.
This process requires submitting a technical dossier including:
- Substance identity
- Physico-chemical properties
- Toxicological and ecotoxicological data
- Classification and labelling
- Identified uses and safe use conditions
The principle of “no data, no market” summarises its importance: without sufficient information, the substance cannot be legally marketed.
Evaluation
Evaluation allows authorities to verify whether the submitted information is adequate and sufficient. It is not merely a document check, but an assessment of whether the available data supports safe use.
Additional testing or clarification may be required, particularly where there are concerns about data quality or inconsistencies in the risk assessment.
Authorisation
Authorisation focuses on substances of very high concern (SVHC), such as those with carcinogenic, mutagenic, or reproductive toxicity properties, or those that are persistent and bioaccumulative.
These substances may be included in Annex XIV, meaning their use is only allowed if specifically authorised. The objective is to progressively replace them with safer alternatives whenever possible.
Restriction
Restrictions allow the limitation or prohibition of certain substances when they pose an unacceptable risk. These measures may affect:
- Specific uses
- Maximum concentrations
- Market availability in certain products
This mechanism has a direct impact on formulation and product development.
REACH Registration in Practice
Registration is not a simple administrative exercise. It involves a full technical evaluation of the substance and its conditions of use.
As production or import volumes increase, so do the data requirements. For higher tonnage levels, a Chemical Safety Report (CSR) is required, including:
- Hazard assessment
- Exposure assessment
- Risk characterisation
In addition, exposure scenarios must be developed to describe how the substance can be used safely under different conditions. These are integrated into extended Safety Data Sheets (eSDS).
Altogether, this makes registration a key tool for structuring technical information and ensuring consistency across the supply chain.
SVHC Substances and the Candidate List
Substances of Very High Concern (SVHC) represent one of the most critical aspects of REACH. Their inclusion in the Candidate List significantly increases regulatory scrutiny and obligations.
Key implications include:
- Communication obligations along the supply chain
- Possible notification to ECHA
- Risk of future restriction or authorisation
- Commercial impact and need for substitution
For this reason, continuous monitoring of this list is essential to anticipate regulatory changes.
Communication in the Supply Chain
REACH places strong emphasis on information flow across the supply chain. The safety of a substance does not depend solely on its assessment, but also on how effectively that information is communicated.
Safety Data Sheets (SDS) are the main tool for conveying:
- Hazard information
- Risk management measures
- Conditions for safe use
Where applicable, this information is expanded through exposure scenarios, ensuring greater consistency and traceability.
Relationship Between REACH and CLP
REACH and CLP operate as complementary frameworks. While REACH focuses on risk management, CLP defines how hazards must be classified and communicated.
This means both regulations must be applied consistently. An incorrect classification can affect SDS content, registration data, and overall risk assessment, leading to regulatory inconsistencies.
Impact of REACH on the Cosmetics Sector
Although finished cosmetic products are regulated under Regulation (EC) No 1223/2009, REACH has a direct impact on the sector.
It particularly influences:
- Raw material selection
- Toxicological evaluation within the CPSR
- Substance restrictions
- Availability of ingredients
This means cosmetic compliance cannot be assessed in isolation, but must be considered within a broader regulatory framework.
Common Errors in REACH Application
Despite its long-standing implementation, common issues still arise:
- Failure to verify whether a substance requires registration
- Ignoring restrictions listed in Annex XVII
- Not monitoring updates to the Candidate List
- Maintaining outdated SDS
- Lack of consistency with CLP
These issues are often due to insufficient regulatory follow-up rather than lack of initial knowledge.
SHAPYPRO’s Technical Approach
The correct application of REACH requires both regulatory knowledge and technical judgement. It is not just about meeting requirements, but about properly interpreting data and understanding its impact on product safety.
In this context, SHAPYPRO integrates REACH analysis into a broader regulatory strategy, ensuring consistency between:
- Substance registration and use
- CLP classification
- Safety Data Sheets (SDS)
- Safety assessment (CPSR)
This approach allows potential regulatory risks to be anticipated and strengthens the robustness of the technical dossier.
Conclusion
The REACH Regulation is one of the cornerstones of European chemical legislation, establishing a comprehensive system for controlling chemical substances.
Its correct application requires not only technical expertise, but also continuous monitoring and alignment across different regulatory frameworks. In sectors such as cosmetics, its impact is particularly significant, as it directly affects formulation, safety evaluation, and product viability.