What Are Skin Sensitizers?
In recent years, we have increasingly discussed allergies and observed a rise in the number of allergic individuals.
The human immune system protects the body from harmful elements through a series of defensive mechanisms. An allergy (or sensitization) is a specific reaction produced by the immune system when exposed to certain substances (allergens), which are usually harmless to most people. These allergens are present in the environment, even in minimal quantities, in numerous consumer products (such as medications, cosmetics, tattoos, foods, toys, clothing, etc.). Allergens can cause an allergic reaction when they come into contact with the skin and/or eyes, or if inhaled, ingested, or injected. Repeated contact with skin sensitizers can lead to permanent sensitivity to a specific allergen; to avoid symptoms, sensitized individuals must avoid exposure to the allergen.
Chemical substances that can induce a skin allergic reaction are known as skin sensitizers. “Skin sensitization” is a toxicological endpoint under the CLP regulation, which requires specific labeling for skin sensitizers. According to the “Call for Evidence on skin sensitizing substances in consumer mixtures” document, over 1,200 chemicals have a harmonized classification as skin sensitizers in Europe. Additionally, following the application of REACH and CLP regulations, an even larger number of substances have been self-classified as skin sensitizers by registrants/notifiers.
Types of Skin Sensitizers
There are two different types of skin sensitizing substances: chemicals and proteins found in raw materials. Skin allergy to chemicals typically develops over time, while protein-induced allergies can manifest very quickly.
Risks in Consumer Products
Although consumer products are generally considered safe for health, there is a risk of contact allergies from products containing sensitizing substances, such as:
– Nickel and its compounds, found in many consumer products like jewelry, watches, jeans buttons, keys, and euro coins, as well as various medical products like stents and prostheses, and permanent makeup products.
– P-phenylenediamine in cosmetics.
– Fragrances, not only in traditional products like perfumes, deodorants, aftershaves, toothpaste, mouthwashes, and other cosmetics but also in household and industrial products, topical medications, and toys.
– Chromium, used in leather products.
Why Do Allergies Develop?
Allergies develop due to a combination of genetic and environmental factors. Repeated exposure to sensitizing substances is an environmental factor. Industrialization has led to increased exposure to more chemicals compared to the past, resulting in a significant rise in the prevalence of allergic diseases such as asthma and contact dermatitis. According to the ECHA website, it is estimated that up to 5 million people in Europe are already sensitized to chemicals in finished textile and leather articles, with up to 180,000 new cases of sensitization occurring each year. According to the European Agency for Safety and Health at Work, occupational skin diseases cost the EU hundreds of millions of euros annually due to millions of lost workdays.
What Can Be Done About Occupational Exposure?
– Assess the substances used in the workplace and ensure workers are aware of the sensitizing substances they are exposed to and are trained in safe working methods.
– Eliminate or substitute sensitizing substances, or limit the duration and frequency of exposure to sensitizing substances, as well as the number of exposed individuals.
– Reduce skin contact with sensitizers through measures such as: adopting certain workplace practices (e.g., ventilating premises, using splash guards and screens); providing appropriate, adequate, and accessible personal protective equipment (PPE); supplying proper cleaning equipment; developing a skin protection plan (including instructions and measures to protect/clean/treat the skin before/during/after work, so that the worker can monitor their skin and understand the benefits and limitations of skin protection measures).
What Is the EU Doing to Protect Consumer Health?
To protect the health of both workers and consumers, legal regulation and specific risk assessment are necessary, covering every possible human exposure to a sensitizing substance or mixture. The EU seeks to identify sensitizers based on data collected by the industry on substances present on the market. The collected data are screened, and when a new potential concerning substance is identified, appropriate risk management measures can be implemented. Thanks to the REACH and CLP regulations, impacting numerous specific sector regulations (detergents, cosmetics, biocides, toys, etc.), skin sensitizing substances can be legally regulated and labeled, and depending on exposure, their content in consumer products can be reduced or eliminated (e.g., through restrictions).
Example: Chromium
Chromium has been used for many years in leather products such as shoes, gloves, and bags. Under the REACH regulation, a restriction was adopted to reduce the risk of skin sensitization induced by direct or indirect contact with leather articles, or products with leather parts, containing Chromium VI: under this restriction, such articles in contact with the skin cannot be placed on the market if they contain Chromium VI in concentrations equal to or greater than 3 milligrams per kilogram (mg/kg – 0.0003% by weight) of the total dry weight of the leather.
Call for Evidence
Given the high number of sensitizing substances in consumer products and the increasing incidence of contact allergies, the competent authorities of France, Germany, and Ireland believe a new assessment of the occurrence of further regulatory actions on these substances is necessary. They are therefore issuing a Call for Evidence regarding the uses of substances known as skin sensitizers in consumer products to evaluate if risks are adequately controlled under specific conditions and to assess what the impact of further risk management measures would be on society.
Who Should Respond to the Call for Evidence?
The call is addressed to companies (manufacturers, importers, formulators, distributors, etc.), trade associations, scientific bodies, member state authorities (including consumer associations, health insurance bodies) with relevant information regarding:
– Type of use/application and sector information;
– Measures in place to minimize consumer exposure (e.g., formulation changes, concentration reduction, specific use conditions, specific packaging);
– Experience with efforts to substitute sensitizers, reasons for non-substitution, availability of alternatives;
– Data on the sensitizing potential of substances;
– Data on the technical functions of sensitizers in mixtures and/or their safe use in consumer products;
– Epidemiological data on allergic contact dermatitis and other health-related information, including healthcare costs.
The survey does not include substances used in cosmetic products as defined by Directive 76/768/EEC (under REACH regulation, article 67).
Information can be submitted confidentially until September 30, 2022, and will be treated as such by the competent member state authorities.
More Information
For further clarification, interested parties can contact the German competent authority at the email address: chemg@baua.bund.de.
To view the invitation, access the link: https://echa.europa.eu/it/calls-for-comments-and-evidence
**1** The European Cosmetics Directive 76/768/EEC was repealed by Regulation (EC) No. 1223/2009, which came into full effect on July 11, 2013.
