The use of heavy metals in cosmetic products is explicitly banned in the UK and the EU under Annex II of the UK and the EU Cosmetics Regulations.
Heavy Metals (e.g., lead, arsenic, mercury, antimony, chromium) are naturally present in the both the environment and in raw materials, this makes it common for trace amounts to get carried into cosmetic products during manufacture or storage. As a product manufacturer or brand it is important to understand the risks heavy metals pose and the different regulations that cosmetic products need to adhere to around the world to get to market. At ADSL we generate detailed product analysis to support your product and are able to make recommendations on production methods or formulation to help your product meets its regulatory requirements.
Why an explicit ban doesn’t mean zero heavy metals
If you didn’t read our previous article ‘Heavy Metals analysis: What is it, why is it important and how we help.’ It is important to understand that it is impossible to remove all trace heavy metals from cosmetic products and formulations. The UK and EU Cosmetics Regulations allow for the fact that products may contain ‘unavoidable traces’ and crucially this doesn’t indicate that the raw ingredient or finished product is unsafe.
It may also seem surprising but there are actually no official maximum tolerable trace levels in either the UK or the EU regulations. In fact, rather than specifying exactly what constitutes an ‘unavoidable trace’, each impurity or trace of heavy metals must be assessed on an individual basis to ensure its presence does not pose any risk of harm to human health. (This process forms part of the safety assessment as required under Article 10 and Annex I of the EU and UK Cosmetics Regulations.)
Who are the CTPA and what is their role?
The CTPA, or Cosmetic, Toiletry & Perfumery Association represents all types of companies involved in making and selling cosmetic and personal care products. It effectively acts as a voice to the UK industry, offering advice and training to help ensure regulations are understood and met.
The CTPA have made various statements about trace heavy metals in products, including one on Heavy Metals in general, and more specifically about Antimony, Chromium, Lead and Mercury. These can help with further understanding.
Where to find international guidance
The International Cooperation on Cosmetics Regulation (ICCR) is an international voluntary group of cosmetics regulatory authorities from Brazil, Canada, Chinese Taipei, the European Union, Israel, Japan, Republic of Korea, and the United States. They meet annually to discuss cosmetics safety and regulation across the globe.
The group has issued these guidelines on heavy metal traces:
- 2016 – Acceptable Trace Mercury Levels in Cosmetic Products Report.
- 2013-12 Recommendation on Lead Traces in Cosmetics.
- 2011-04 ICCR Principles for Handling Traces in Cosmetics.
While the EU and UK do not issue specific limits for traces of heavy metals other countries do.
What are the international limits?
The CTPA is unable to provide an exhaustive list of international limits imposed, but this is the guidance
that is currently available:
ASEAN (The Southeast Asian Nations)
The limits identified by countries in the ASEAN region:
- Arsenic: 5 ppm
- Lead: 20 ppm
- Mercury: 1 ppm
The Canadian Authorities have released guidance on heavy metal impurities in cosmetics. This guidance can be found on the Health Canada website. The focus is on the heavy metals with known significant toxicological properties and the recommended limits are:
- Antimony: 5 ppm
- Arsenic: 3 ppm
- Cadmium: 3 ppm
- Lead: 10 ppm
- Mercury: 3 ppm
A heavy metal test report is required from either an accredited laboratory in the Country of Origin or from the Dubai Municipality (when requested). The metals investigated are Lead, Zinc, Cadmium, Mercury, Arsenic and Chromium. However, limits for these heavy metals have not been published.
Some limits are identified in the Bureau of Indian Standards (BIS):
- IS 4707 (Part 1):2009 (reaffirmed 2006) which lists the permitted colours is identical to Annex IV, and
- IS 7884: 2004 (Reaffirmed 2009) Shampoo, synthetic detergent based – specification IS 6608: 2004 (Reaffirmed 2009) – specification.
The limits in these Standards are:
- Arsenic: 2 ppm
- Lead: 20 ppm (maximum)
- Mercury: 0 ppm
They also provide a maximum limit of 100 ppm for overall traces of heavy metals (not including lead).
The Japanese Regulations do not currently stipulate the level of traces in final products. However, the Ministry of Health and Welfare Notification No.331 of 2000 concerning Cosmetics, regulates ingredients which must not be formulated in cosmetics, and ingredients such as UV filters, preservatives, etc., of which inclusion is limited.
Ingredients that are prohibited are listed but although this list includes a number of heavy metals, no limits are identified.
The limits identified in Thailand are:
- Lead: 20 ppm (except lead acetate – 1.75%)
- Mercury: 0.5 ppm (specific limit of 0.0065% for organomercury)
German guidance goes further than the rest of the EU
The German authorities, Federal Office of Consumer Protection and Food Safety, have issued guidance recommending specific limits for heavy metals in cosmetic products.
The aim of providing these, rather than defining an acceptable safety threshold, was to analyse the state of the market and to have an idea of the technically unavoidable. If the trace levels of Heavy Metals are above the recommended levels, they will then request the Responsible Person to justify and include the reasoning in the safety assessment.
Measuring trace levels and safety analysis
As the safety of cosmetics is so important to human health and because regulations vary so much across regions, it’s vital to be able to measure and analyse cosmetic samples with high levels of accuracy. At ADSL we deliver industry leading heavy metals analysis using our own rapid and effective ISO 17205 accredited microwave digestion method for testing heavy metal presence within product samples. This means we can find and measure even the most minute traces.
We also have experts who understand the international landscape and can advise on exactly what’s required depending on your situation and location. They can also offer support to optimise and improve product management, formulation, or efficacy where possible.
Can we help you with your product?
It doesn’t matter where you’re based in the world, we can provide detailed product testing and analysis for heavy metals from our purpose-built facilities. You can also find out more about our Heavy Metal Testing in our previous article ‘Heavy Metals analysis: What is it, why is it important and how we help.‘
When you are ready to get started or if you would like to find out more, please get in touch:
Call us on +44 (0) 1803 520 048 | Mon-Fri 9-5pm (GMT)
Email us: email@example.com.
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