Heavy metal content in cosmetic products: a comparative review on permissible level in global regulatory requirements and available analytical tests
Podium 75
Presented by: Jerry Yu
Background: Heavy metals are generally not permitted to be added individually in cosmetic products. However, they are naturally occurring elements and present in mineral and natural ingredients like pigments and herbal extracts. Heavy metals are identified to have potential health risks like carcinogenic and mutagen potency. Hence, evaluating potential risk of unavoidable impurities can be crucial for consumers’ health. The aim of this review is to have a comparative review on major global cosmetic markets (USA, Canada, EU, UK and China) on limitation and evaluation of heavy metal contamination in cosmetic products to ensure finished products’ safety.
Method: For this comparative study, two types of regulatory systems: self-regulatory and obligatory registration were chosen. For markets with self-regulatory system, United Kingdom, Canada and European Union with mandatory products’ notification and United states as a market with non-mandatory notification were chosen. For market with obligatory registration China and India were considered for this comparison. In addition to obligatory regulations, horizontal regulatory regulation that may affect evaluation of heavy metal contamination in cosmetic products were investigated. Furthermore, acceptable analytical tests with relevant limit of detection used to evaluate heavy metals content have been reviewed.
Discussion and conclusion: Based on the EU and UK Regulation, traces of unavoidable impurities under Good Manufacturing Practice (GMP) are permitted in cosmetic products. While there is no specific limit set in the regulation for unavailable impurities, the responsibility of final products’ safety is on shoulders of qualified safety assessors. Even though there are substantial guidelines on evaluation of systemic dosage exposure for potential carcinogen materials, the decision on threshold of concern for such impurities is not an easy process. In some of the EU member of states like Germany, a set values for "technically avoidable" metal content to be used in cosmetics was considered and consequently a monitoring scheme in place to review the levels for finished products on the market. In the UK, the new scientific committee under supervision of Office for Product Safety and Standards (OPSS) is yet to comment on this matter and still follows the same guideline of the EU regulation 1223, 2009. In addition, horizontal regulations in the EU and UK which can impact restriction of heavy metals in finished products. In both regulations, there is a list of approved colourants (Annex IV) with certain restriction for impurities of colorants (Annex IV). Above all, for placing any chemical ingredients on the market compliance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the UK counterpart (UK REACH) is an obligation. Under REACH, articles (that is, finished products) cannot be sold if they exceed limits for certain chemical substances, such as heavy metals.
In the United States, Food and Drug Administration (FDA) addresses some heavy metals as cosmetic ingredients or impurities in colour additives while Health Canada has a guideline on heavy metal impurities in cosmetic products. In none of the countries under self-regulatory system, there is a specific approved method for evaluation of heavy metal contamination in finished cosmetic products, though ISO 21392:2021 is considered as an acceptable standard for the market.
In China, Chinese safety and Technical standard 2015 has a set testing and approved method for evaluating cosmetic products’ impurities before being placed on the market. In India, the Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945 which recently replaced by Cosmetic rules 2020 has specific set limit for heavy metals only for synthetic organic and natural colours.
In conclusion, after evaluation of definition of heavy metals in different regulatory systems and discrepancies on limits it can be concluded that there is a lack of harmonisation which can lead to confusion for authorities and respectively ingredients’ manufacturers. The different approach on setting a standard for heavy metals contamination which may be rooted either in political issues or difference in risk assessment approach (hazard identification versus risk assessment) may lead to serious impacts on consumers’ trust in safety of cosmetic products. This lack of harmonisation can also impact manufacturers and suppliers of ingredients in global supply chain connected internationally
Method: For this comparative study, two types of regulatory systems: self-regulatory and obligatory registration were chosen. For markets with self-regulatory system, United Kingdom, Canada and European Union with mandatory products’ notification and United states as a market with non-mandatory notification were chosen. For market with obligatory registration China and India were considered for this comparison. In addition to obligatory regulations, horizontal regulatory regulation that may affect evaluation of heavy metal contamination in cosmetic products were investigated. Furthermore, acceptable analytical tests with relevant limit of detection used to evaluate heavy metals content have been reviewed.
Discussion and conclusion: Based on the EU and UK Regulation, traces of unavoidable impurities under Good Manufacturing Practice (GMP) are permitted in cosmetic products. While there is no specific limit set in the regulation for unavailable impurities, the responsibility of final products’ safety is on shoulders of qualified safety assessors. Even though there are substantial guidelines on evaluation of systemic dosage exposure for potential carcinogen materials, the decision on threshold of concern for such impurities is not an easy process. In some of the EU member of states like Germany, a set values for "technically avoidable" metal content to be used in cosmetics was considered and consequently a monitoring scheme in place to review the levels for finished products on the market. In the UK, the new scientific committee under supervision of Office for Product Safety and Standards (OPSS) is yet to comment on this matter and still follows the same guideline of the EU regulation 1223, 2009. In addition, horizontal regulations in the EU and UK which can impact restriction of heavy metals in finished products. In both regulations, there is a list of approved colourants (Annex IV) with certain restriction for impurities of colorants (Annex IV). Above all, for placing any chemical ingredients on the market compliance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the UK counterpart (UK REACH) is an obligation. Under REACH, articles (that is, finished products) cannot be sold if they exceed limits for certain chemical substances, such as heavy metals.
In the United States, Food and Drug Administration (FDA) addresses some heavy metals as cosmetic ingredients or impurities in colour additives while Health Canada has a guideline on heavy metal impurities in cosmetic products. In none of the countries under self-regulatory system, there is a specific approved method for evaluation of heavy metal contamination in finished cosmetic products, though ISO 21392:2021 is considered as an acceptable standard for the market.
In China, Chinese safety and Technical standard 2015 has a set testing and approved method for evaluating cosmetic products’ impurities before being placed on the market. In India, the Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945 which recently replaced by Cosmetic rules 2020 has specific set limit for heavy metals only for synthetic organic and natural colours.
In conclusion, after evaluation of definition of heavy metals in different regulatory systems and discrepancies on limits it can be concluded that there is a lack of harmonisation which can lead to confusion for authorities and respectively ingredients’ manufacturers. The different approach on setting a standard for heavy metals contamination which may be rooted either in political issues or difference in risk assessment approach (hazard identification versus risk assessment) may lead to serious impacts on consumers’ trust in safety of cosmetic products. This lack of harmonisation can also impact manufacturers and suppliers of ingredients in global supply chain connected internationally