ADVICE ON SAFETY ASSESSMENT REQUIREMENTS.PLEASE PRINT THIS PAGE FOR YOUR REFERENCE. If you'd like to view a version of the official guide, click this link If you'd like to view the Trading Standards advice booklet, click this link Because current EU legislation and the requirement for safety assessments on cosmetic products has now been in existance for several years we have taken the opportunity to completely revise our website advice. We now also provide various solutions to our customer's problems of having their own finished products properly and legally assessed so as they can be legally sold within th EU. We can provide our customers with various levels of assistance as follows... 1. Pre-assessed product which does not therefore require further safety assessment, nor does it require the customer to keep their own Product Information File, but product should be batch labelled with the batch codes we supply with the product for traceability. 2. Affordable, limited, safety assessment packages developed in conjunction with experienced industry consultants which allow the small business/crafter to produce entirely bespoke finished products using various sized 'packages' at fixed prices using product sourced exclusively from ourselves, or with a supplement, to include product sourced from other recognised UK stockists. Packages can be affordably added to within certain restrictions, allowing a product range to grow and develop without the need for complete re-assessment at a later stage. 3. Affordable Comprehensive safety assessment packages based on a wider range of bases and materials available from most recognised UK suppliers which allows the more adventurous individual/small business the opportunity to work with a wider-ranging selection of ingredients that are commonly used in many soap, toiletry and cosmetic products and to produce genuinely individual product ranges. Again, these packages can be added to as product ranges grow and evolve. 4. Bespoke assessments which can also include assistance in product formulation, challenge and stability testing, technical advice and ongoing product support which is handled directly from our retained consultants. We realise that the subject and content of safety assessment packages is not a familiarity to many of our customers. We have tried to lay out our package purchases on our shopping site in an understandable and simple manner, but for your guidance we have prepared the following separate advice page. For those of you reading this page for it's informational content about compliance with legislation, we have given below a basic summary of how to comply with legislation as it currently stands and what it requires you, as the manufacurer of your own products to be doing, in order to be able to legally sell your products within EU member states. The manufacturer (you) should prepare a Product Information File (PIF) which should contain all information regarding manufacturing method, ingredients, MSDS for all ingredients, allergen information, labelling detail, batch records and traceability. This file should be kept available for viewing by anyone requesting so. Batches... Each 'batch' of product should be issued with a batch number and have full ingredients and origin of ingredients record written and kept for scrutiny if required. Batch numbers should appear on any product labelling to ensure it can be accurately linked to the batch information for traceability purposes. Labelling... all product labelling should comply with INCI legislation, which states that the INCI names for ingredients should be clear and legible either on the product itself, or where not appropriate, maybe because of size or where a product is offered unwrapped, should be clearly visible at the point of display or on any over-packaging such as outer boxes or wrap. Ingredients should use approved INCI names for each one. Ingredients should be listed in descending order of weight as they are included in the manufacture of the product and should use the INCI names for each ingredient used. For a guide to INCI terminology for common ingredients, click this link. Natural Soaps... for a naturally saponified soap, which would have oils and lye in manufacture, but would then not have any significant amounts of either oils nor lye remaining in the final product, the 'soap' ingredients are listed in approved terminology relating to the finished substances. E.G. Soap made from Olive Oil and Lye would be listed as 'Sodium Olivate'. There is no need to refer to oils as their INCI names nor to Lye (Sodium Hydroxide), as it is not present in the finished soap. Ingredients of 1% or less concentration can appear in any order at the end of the ingredients list usually with the colour last.. Allergens (sensitisers)... certain allergens present in many essential oils and fragrance oils must be included in the INCI labelling in cases where they exceed 0.01% in rinse-off products (soaps, shampoos etc.) and in 0.001% in leave-on products (moisturising creams etc.). Separate specific advice for this is available by clicking this link. Product labelling should also include a 'point of contact' address for the manufacturer (you). See our guide.. As well as the PIF and Labelling issues, there is a legal requirement for the manufacturer (you) to hold a safety assessment for the products you are selling if selling within the EU. A safety assessment should be carried out by a 'competant' person and in choosing this person or organisation you should ensure that they are experienced in all aspects of the products you intend to sell and that they are backed-up by their own Professional Indemnity Insurance, which will be your protection financially if there should be any litigation brought against you should anyone experience an adverse reaction to any of your products. Once completed, your assessment is valid forever. It does not require annual renewal. The DTI and Trading Standards can provide fuller information on the legislation and how to comply. Their services are FREE and their specific advice on labelling can be very useful. Information on the listing of allergens in finished products is available here. Useful PDF list giving INCI names for common ingredients, here. THESE GUIDELINES ARE BASED UPON OUR OWN EXPERIENCES AND UNDERSTANDING OF THE LAW AS IT STANDS IN THE U.K. Safety Assessment Packages and Services
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