CHEMICAL SUBSTANCES SAFETY: REACH

Thousands of chemical substances are produced, consumed, and traded worldwide. The chemical sector plays a significant role in the global economy, showing consistent growth trends, albeit affected by the 2008 global economic crisis and the 2020 health crisis. In 2022, global chemical production was valued at €5,622 billion. With a 43% share amounting to €2,390 billion, China is the world’s leading producer. The European chemical industry ranks second with €764 billion and a 14% share (Figure 1).

Italy, with a production value of over €66 billion in 2022, remains the third-largest producer in Europe—after Germany and France—and twelfth globally. Around 2,800 chemical companies operate in Italy, employing over 112,000 people (Federchimica, 2023). Italian chemical production is primarily concentrated in three sectors:

• Basic chemicals and fibres, accounting for about 40% of Italy’s chemical production value, produce key components for downstream industries. This includes petrochemical products and derivatives, basic inorganics (chlorine, soda, sulphuric acid), chemical fibres, fertilizers, dyes and pigments, and technical gases.

• Fine and specialty chemicals, representing almost 44% of the total, include auxiliary products for industry, paints and inks, and plant protection products, serving as intermediates for other industrial sectors.

• Consumer chemicals, making up over 16%, include chemicals intended for final consumers such as specific paints and coatings, detergents, cosmetics, and fragrances.

Although chemical activity is distributed across the entire country, there is a higher concentration in Northern Italy, which accounts for about 77% of sector employment (almost 41% in Lombardy), compared to 12% in Central Italy and around 10% in the South (Federchimica, 2023).

The registration of chemical substances produced or imported above one tonne per year is the first and most important requirement under the REACH Regulation to ensure the safe use of chemicals. From the entry into force of REACH up to 31 December 2023, 104,945 registration dossiers concerning 22,566 substances were submitted to the European Chemicals Agency (ECHA) (Figure 2). Most registrations were submitted by companies based in Germany (28%), France (11%), and the Netherlands (10%). Italy, with 9,590 registrations (9%) covering 4,955 substances, ranks fourth among EU Member States (Figures 3 and 4).

ECHA uses the information provided in registration dossiers to build a database that also supports other regulatory processes. The goal is both to define appropriate risk management measures and to make chemical substance information publicly accessible. These data are fundamental for companies in preparing safety data sheets and communicating safe use conditions along the supply chain. Therefore, ensuring the quality of registration dossiers is crucial, which means information must be compliant, complete, and easily accessible.

ECHA conducts two types of dossier evaluation to ensure compliance:

• Compliance Check (CCH) (Article 41)

• Examination of Testing Proposals (TPE) (Article 40)

From 2009 to 2023, ECHA, with support from Member States, conducted 4,072 compliance checks and 2,319 testing proposal evaluations. In cases of non-compliance or for all TPEs, ECHA sends a request for additional information to the registrant. Compliance checks assess:

• the completeness and adequacy of submitted information;

• the accuracy of the chemical safety assessment;

• the appropriateness of risk management measures.

Compliance checks are primarily targeted at substances (or groups of substances) that raise potential concern due to their hazard or exposure, where improving data quality can significantly enhance safety.

Testing proposals are mandatory for registrations above 100 tonnes/year for data required under Annexes IX and X of REACH. ECHA reviews all proposals with the aim of avoiding unnecessary testing, especially on vertebrate animals, which is only allowed when absolutely necessary and as a last resort. Since 2009, ECHA has issued 2,381 compliance decisions covering 9,959 information requirements due to identified data gaps. Additionally, it adopted 1,589 decisions on testing proposals, addressing 3,109 information requirements (Table 3).

Substances registered in large volumes or with hazardous properties undergo further evaluation by Member State competent authorities as part of the Community Rolling Action Plan (CoRAP), coordinated by ECHA over a three-year period. Priority criteria include hazard, exposure, and total volume on the market. The evaluation aims to confirm (or dismiss) initial grounds for concern and identify appropriate risk management measures. It involves a thorough review of the registrants' chemical safety reports, may request further information, and concludes with an evaluation report. Under the previous legislation, only about 140 substances were evaluated over twenty years.

Under REACH, 321 substances were evaluated between 2012 and 2023 for properties such as carcinogenicity, mutagenicity, reproductive toxicity, sensitisation, PBT (persistence, bioaccumulation and toxicity), and endocrine disruption, especially under relevant exposure conditions (ECHA, 2023b). About 70% of these evaluations led to additional information requests, confirming the validity of the initial concerns for substances included in CoRAP up to the 2024–2026 period (Figure 5).

The evaluation process is also key to implementing REACH's authorisation goals. It was crucial in meeting the objectives of the SVHC Roadmap, which aimed to include all known Substances of Very High Concern (SVHCs) on the Candidate List by the end of 2020. This work continues under the Integrated Regulatory Strategy, which seeks to assign risk management priorities and/or data generation needs for all registered substances by 2027.

Substances on the Candidate List may be added to Annex XIV (Authorisation List). Once listed, these substances may no longer be placed on the market or used after a certain date unless specific authorisation is granted. Through the authorisation process, REACH ensures that SVHCs are gradually replaced by less hazardous substances or technologies.

Since 2008, 235 substances or substance groups have been identified as SVHCs and added to the Candidate List (Figure 6), and 59 substances have been included in Annex XIV. Annex XVII contains all adopted restrictions, including those from the previous Directive 76/769/EEC. Thus, restrictions have served as a risk management tool for over forty years.

As of 31 December 2023, Annex XVII included 77 entries referring to substances or substance groups subject to restriction, some of which include numerous chemicals. Since the entry into force of REACH, the number of restriction proposals submitted by Member States and ECHA has reached 530 (Table 1).

From 2009 to 2023, ECHA’s Risk Assessment Committee adopted about 570 opinions on harmonised classification and labelling (CLH) proposals (Table 2), while the Classification and Labelling Inventory contains data on the classification and labelling of approximately 270,000 substances.