SAFETY OF CHEMICALS: REACH

Thousands of chemicals are produced, consumed, and traded worldwide. The chemical sector plays a significant role in the global economy with growing development trends, although still marked by the 2008 global economic crisis and the 2020 health crisis. Global chemical industry production was valued at €5,031 billion in 2024. With a 46% share, China is the world's leading producer, accounting for €2,298 billion. The European chemical industry, with €635 billion in turnover and a 13% share, is the world's second-largest producer (Figure 1).

Italy, with a production value of over €65 billion in 2024, is confirmed as the third-largest European producer after Germany and France, and the tenth globally. There are more than 2,800 chemical companies active in Italy, employing over 113,000 people (Federchimica, 2025). Italian chemical production primarily develops across three sectors:

• Basic chemicals and fibers, which represent approximately 45% of the chemical production value in Italy and produce the fundamental constituents of the value chain for downstream companies. This includes petrochemicals and their derivatives, basic inorganics (chlorine, soda, and sulfuric acid), chemical fibers, fertilizers, dyes and pigments, and technical gases;
• Fine and specialty chemicals, covering over 41% of the total and including industrial auxiliaries, paints and inks, and plant protection products, providing intermediate goods to other industrial sectors;
• Consumer chemicals, representing about 14%, which includes chemical products destined for the final consumer, such as certain types of paints, detergents, cosmetics, and perfumes.

Although activities are distributed across the national territory, the highest concentration is in Northern Italy, with nearly 78% of the sector's employment (approximately 40% in Lombardy), compared to about 12% in Central Italy and 10% in Southern Italy (Federchimica, 2025).

The registration of chemical substances produced and imported above one tonne/year is the first and main obligation of the REACH Regulation to ensure the safe use of chemicals. From the entry into force of REACH until December 31, 2024, 108,391 registration dossiers for 22,872 substances (Figure 2) have been submitted to the European Chemicals Agency. The majority of registrations were made by companies located in Germany (28%), France (11%), and the Netherlands (11%). Italy, with 9,933 registrations (9%) relating to 5,086 substances, ranks fourth among Member States (Figures 3 and 4).

ECHA, using the information provided in the registration dossiers, maintains a database that is also useful in other regulatory processes, with the aim of both defining appropriate risk management measures and making information on chemical substances available to the public. This information serves as the starting point for companies to prepare Safety Data Sheets and to communicate conditions for the safe use of substances throughout the supply chain. It is therefore essential to ensure the quality of registration dossiers, ensuring that the information complies with regulatory requirements and is easily accessible. For this reason, the Agency exercises control over the registration dossiers submitted by companies, carrying out two types of assessment:

• Compliance Check (CCH) (Art. 41);
• Examination of Testing Proposals (TPE) (Art. 40).

Between 2009 and 2024, ECHA, with the support of Member States, conducted 4,335 compliance checks and examined 2,480 testing proposals. In cases of non-compliance for CCHs, and in all cases for TPEs, a request for further information is sent to the Registrant. The compliance check aims to verify:

• The completeness and adequacy of the information provided;
• The compliance of the chemical safety assessment;
• The adequacy of risk management measures.

Compliance checks are primarily targeted at substances (or groups of substances) that raise potential concerns based on hazard or exposure, where improving the quality of information can lead to a significant increase in safety.

Testing proposals must be submitted for registrations exceeding 100 tonnes/year for the information required in Annexes IX and X of REACH. The Agency evaluates all proposals with the goal of avoiding unnecessary testing, particularly on vertebrate animals, which may only be carried out as a last resort when absolutely necessary, avoiding duplication. Since 2009, ECHA has adopted 2,590 decisions on compliance checks concerning 10,987 information requirements where data gaps were identified. Furthermore, the Agency has adopted 1,681 decisions on testing proposals concerning 3,293 information requirements for which testing was originally proposed (Table 3).

Registered substances that are prioritized due to volume and hazard characteristics undergo a more in-depth evaluation by the Competent Authorities of the Member States under the Community Rolling Action Plan (CoRAP), coordinated by ECHA over a three-year period. Priority criteria for selecting substances take into account hazards, exposure, and total volumes placed on the market. The primary purpose of the evaluation is to confirm or dismiss the identified 'initial grounds for concern' and, if necessary, identify the most appropriate risk management measures. The evaluation involves an in-depth review of the chemical safety reports produced by the registering companies, requesting additional information if needed, and includes the drafting of an evaluation report. In the twenty years of application of previous legislation, approximately 140 substances were evaluated.

Under the REACH Regulation, between 2012 and 2024, evaluations were initiated for 327 substances to identify potential hazard characteristics such as carcinogenicity, mutagenicity, reproductive toxicity, sensitization, PBT (Persistence, Bioaccumulation and Toxicity), PMT (Persistence, Mobility and Toxicity), and endocrine disruption, associated with relevant exposure conditions (ECHA, 2025b). To date, a high percentage of evaluations (70%) has led to requests for additional information, confirming the validity of the initial grounds for concern for substances included in the CoRAP process through the 2025-2027 period (Figure 5).

After assessing the available or requested information, the Member States responsible for the evaluation concluded whether 254 substances constituted a risk to human health and/or the environment and decided how to use the information on those substances for regulatory risk management. Member States concluded that for 109 substances, no further EU-level regulatory follow-up was justified, while for 145 substances, further EU-level regulatory follow-up was necessary (harmonized classification and labeling, identification as a substance of very high concern, restriction, or other EU-level risk management measures such as an EU-wide occupational exposure limit) (ECHA, 2025b).

The evaluation process plays a fundamental role in the implementation of REACH. In particular, it was essential for achieving the objective set by the 'SVHC Roadmap' to include all 'Substances of Very High Concern' (SVHC) present on the market in the Candidate List for authorization by the end of 2020. The work initiated with the roadmap continues today with the goal established by the Integrated Regulatory Strategy to prioritize risk management and/or data generation for all registered substances by 2027. Substances on the Candidate List may be moved to the list of substances subject to authorization (Annex XIV of REACH). Once included in this list, companies will not be allowed, as of a certain date, to place these substances on the market or use them unless they have been authorized to do so. Through the authorization procedure, the REACH Regulation ensures that SVHCs are progressively replaced by less dangerous substances or technologies. Since 2008, 242 substances or groups of substances have been identified as SVHCs and included in the Candidate List (Figure 6), while 59 substances have been included in Annex XIV. Annex XVII of REACH, instead, contains all the restrictions adopted, including those from the previous Directive 76/769/EEC. Restrictions are, therefore, a risk management measure that has been active for forty years. As of December 31, 2024, Annex XVII includes 79 entries relating to restricted substances or families of chemical substances, some of which are very numerous. Since the entry into force of the REACH regulation, the number of restriction proposals submitted by Member States and ECHA has been 53 (Table 1). From 2009 to 2024, ECHA's Risk Assessment Committee adopted 625 opinions on harmonized classification and labeling (CLH) proposals (Table 2), while the Inventory contains classification and labeling information for approximately 350,000 substances.