New EU Cosmetic Regulation 1223/2009 and CPSR's
From July 2013 the regulation 1223/2009 comes into force in every EU country and all new safety assessments (now termed Cosmetic Product Safety Report or CPSR) will be required to be much more more detailed than at present. Each ingredient in a recipe will require a so-called margin of safety calculation based on quantifiable referenced toxicity data, whereas under current rules it is acceptable to state that a (well-established) ingredient has been used for many years without reported ill-effects or concerns. The new requirements are given on Annex 1 of the regulation (page 21); see Regulation 1223/2009 on EU website. The new method brings risk assessments of cosmetics in line with those for food additives. It is expected that the price of safety reports will increase steeply to take into account the extra work required. Also, new ingredients that have no chronic toxicity data may in effect not be allowed. This may be particularly relevent to botanical and herbal extracts that don't have a well-defined chemical composition and to certain health supplements that are used in cosmetics. It has also been common practice in the past to write "flexible" safety assessments that allow a wide choice of compositions and variations, but under the new rules this option will normally not be possible.
EF Chemical Consulting are now providing product safety reports (Parts A and B) in compliance with Annex I to EC1223/2009. In the run-up to the change-over date we will be offering customers a choice between new-style and old-style assessments, but after July 2013 only the new-style safety reports will be provided. For oral care products such as teeth whitening products we will only carry out assessments in accordance with the new regulation. Its our intention to continue to offer the best service possible to small and medium-sized businesses and help steer them past the forthcoming changes.
Product Safety Reports and Calculation of Margin of Safety (MOS)
The human toxicity of all substances can be described in terms of local effects such as skin sensitisation and irritancy, and systemic effects, which are potentially more serious. The latter include for instance liver or kidney toxicity, reproductive toxicity, neurotoxicity and carcinogenicity. The safety of each ingredient in terms of its potential systemic toxicity must be calculated under the new regulations. The method involves researching a value in the literature for the NOAEL (No Observed Adverse Effect Level), which is the maximum safe daily level of the substance usually derived from animal chronic toxicity studies. If a reliable NOAEL value can not be found it may be possible to calculate it from related substances (so called structure-activity relationships). EF Chemical Consulting does not carry out any actual toxicity studies on animal or human subjects - we just reasearch the literature and carry out calculations. The margin of safety (MOS) is then calculated from a knowledge of the amount of the substance to which the customer will be exposed each day. The MOS must be greater than 100 to be deemed safe; lower values can not be accepted unless good reasons are given. As an example see margin of safety calculation for lavender oil. Calculations for local toxicity are done differently and must also be detailed on the report.
Customers should check with their supplier that their CPSR's do comply with the regulations and properly reference margins of safety and NOAEL values. We have recently seen product safety reports from 2 different suppliers that do not comply. In one, they only had margins of safety calculated for a few of the ingredients and missed off all the ingredients that were classifed as "non-hazardous" on the safety datasheet (MSDS). In another, they incorrectly used acute toxicity LD50 values instead of the NOAEL to calculate margins of safety. The systemic toxicity classification of substances on an MSDS (which comes under the EU REACH/CPL regulations) only take into account the effects of a single large dose of a substance (acute toxicity), whereas cosmetics involve daily use over a long period of time (chronic toxicity). Comfrey root extract and cyclopentasiloxane are examples of ingredients that have low acute toxicity (i.e. high LD50) but both have relatively high chronic toxicity and the margins of safety can be quite close to 100, depending on the product. The concern with long-term use of comfrey is liver toxicity and the concern with cyclopentasiloxane is reproductive toxicity.
Please call us on 01244-351644 (UK) or email edmund@efchemicalconsulting.co.uk to find out more about our cosmetic safety assessment and labelling services, or to discuss pricing.