CFS - Certificate of Free Sale. According to Department of Health website it only applies to CE marked medical devices.
HACCP - Hazard Analysis & Critical Control Points - A system of food safety management. Accreditation by a registered body to show compliance with the management system. This company would meet the IAF requirement. GWP is a different food safety management system.
Products Analysis & Ingredients - Safety Data sheets, Data sheets are provided by manufacturers of cosmetics containing multiple ingredients.
A good place to find reputable manufacturers of particular cosmetics is at the Formulate and international exhibitions.
Planet & Product Master File - .
Health Certificate -Local councils issue certificates for individual products when requested.
EU legislation notes
1. The EU Chemicals Policy – REACH (Registration, Evaluation & Authorisation of Chemicals).
A brief summary of REACH is set out below:
REACH is the biggest piece of legal text to ever come out of the EC, replacing 40 pieces of legislation.
As it is a Regulation rather than a Directive, it applies as written across all EU member states.
It will be phased in over 11 years, starting in June 2007 until 2018, based on tonnage bands. See http://www.hse.gov.uk/reach/timeline.htm for details.
It creates the European Chemicals Agency (ECHA) which is located in Helsinki.
Upstream Users, i.e. manufacturers and importers that place on the market or use chemicals are required to submit a registration for each substance manufactured or imported into the EU in quantities of 1 tonne or above per year.
Failure to register means that the substance cannot be manufactured in, or imported into, the EU.
Essential oils are in REACH under category NCS – Natural Complex Substances.
Upstream Users were required to pre-register their chemicals during the pre-registration phase, starting on 1st June 2008 and ending on 1st December 2008.
Pre-registration allows upstream users to continue manufacturing and importing their phase-in substances for several years until the registration deadline is reached.
Those who have not pre-registered their substances will not be able to continue manufacturing or importing them without submitting a full technical registration dossier.
Before a chemical can be registered, the applicant must provide information about the characteristics and hazards, if any, associated with that chemical.
Downstream Users (i.e. companies and professionals that use a chemical to make a product/supply a service) must ensure that their particular use of an essential oil is listed within the registration dossier otherwise they can’t use it for that purpose.
In practice, everyone that manufactures a product within the EU will be affected to some degree.
ECHA reports that 143,000 substances had been pre-registered by some 65,000 companies.
REACH has now moved on to the second phase, the formation of Substance Information Exchange Fora (SIEFs).
It is mandatory for potential registrants for the same substance to become part of a SIEF.
They are required to share the information needed to create the registration dossier to prevent duplicate testing, especially on vertebrate animals.
Only one set of animal test data may be generated per substance and as a general rule, there will be one SEIF for each substance identified.
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As of 5th September 2011 the ECHA web site reports that 3455 substance specific SIEFs had been formed and Lead Registrants nominated. The current list of registered substances can be down loaded at: http://apps.echa.europa.eu/registered/registered-sub.aspx#phasein
There can only be one Lead Registrant and one Lead Registrant dossier for a substance.
The Lead Registrant will typically be the company most involved in that substance.
Guidance documents on REACH are available on the ECHA web site at http://guidance.echa.europea.eu/guidance_en.htm
HSE is the UK competent and enforcement authority for REACH.
In May 2010 ECHA published it’s report on the first coordinated REACH enforcement project checking pre-registrations, registrations and, where applicable, the provisions for Safety Data Sheets (SDS), based on the core principle of REACH, no data, no market. 24% of companies inspected failed in their REACH obligations, 11% had no SDS and 20% failed the language and format criteria for SDS. Further such internationally coordinated enforcement exercises are planned on further REACH restrictions and on CLP compliance.
SDS there is an excellent guidance document on this on the HSE web site at www.hse.gov.uk searching under REACH.
On 20 May 2010 Commission regulation (EU) No 453/2010 amending Regulation (EC) No 1907/2006 (REACH) was published in the official journal (L333) This amendment updates the Requirement for the Compilation of Safety Data Sheets (SDS) to bring them in line with the requirements of the Globally Harmonised System (GHS) for the classification, labelling and packing of chemicals adopted by EC as the CLP regulations. This regulation retains the 16 categories on the current SDS but changes some of the wording and the arrangement of information in some sections. Members should ensure that they are familiar with these changes since they come into force on 1 December 2010 for substances and on 1 June 2015 for mixtures. The implementation is subject to the phase in conditions where changes can be deferred for up to 2 years for products already on the market on 1 December 2010. Copies of this regulation are available at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:133:0001:0043:en:PDF.
The final version of the EC guide to the compilation of safety data sheets was published in September
2011 and can be downloaded at: http://guidance.echa.europa.eu/docs/guidance_document/sds_en.pdf
The first REACH registration deadline was 1 December 2010 (quantities over 1000 Tonnes/yr.) and affected a small number of essential oils in particular sweet orange oil, members may begin to see SDSs with enhanced detail incorporating chemical safety reports and product usage categories as a result. Most of the commonly traded essential oils will be registered in phase 2 (100 – 1000 T/yr.) and 3(1-100 T/yr.), 1 June 2013 and 1 June 2018 respectively and enhanced SDSs will only be generally available when these oils are registered.
Over 60% of the commonly traded essential oils under current estimates (EFEO data) are not subject to REACH i.e. not manufactured or imported in quantities greater than 1 T/yr.
2. The CLP Regulation (European Legislation on the Classification, Labelling & Packaging of Substances & Mixtures) and the GHS (Global Harmonised System on the Classification & Labelling of Chemicals)
The CLP Regulation is a direct-acting Regulation and adopts in the European Union, the internationally agreed Global Harmonised System on the classification and labelling of chemicals, known as the 'GHS' see http://www.hse.gov.uk/ghs/eureg.htm.
The aim of the GHS is to have, worldwide, the same criteria for classifying chemicals according to their health, environmental and physical hazards and the same hazard communication system for labelling and safety data sheets.
The CLP Regulation entered into legal effect on 20 January 2009 with a 7 year transitional period ending on 1 June 2015.
After the transition period the CLP Regulation will replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC), enacted in the UK by CHIP.
There is a basic introduction to the CLP Regulations for professional suppliers/users on the EC web site see http://ec.europa.eu/enterprise/sector/chemicals/files/ghs/clp_introduction.pdf and detailed guidance on the ECHA website see http://echa.europa.eu/classification/clp_guidance_eu.asp.
In order to give industry and users the time to adapt to this new system suppliers will be able to continue applying the ‘old’ legislation during the transitional period (see below CLP and CHIP).
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Under the REACH Regulation companies that import/manufacture a substance(s) classified as hazardous under CLP irrespective of quantity imported/manufactured must notify ECHA using the REACH-IT website to include their substance(s) in the Classification and Labelling (C&L) Inventory unless they have already submitted a full registration under REACH. The effective date is 1st December 2010 and importers/manufacturers that place a substance(s) on the market on that date have 1 month to notify ECHA. After 1st December 2010 notification must be made within one month of placing a substance(s) on the market for the first time after 1st December 2010. The REACH-IT website is fully active full details and guidance is available on the ECHA web site: http://echa.europa.eu/home_en.asp go to CLP on menu
Substances covered by the notification requirement are:
(1) All "substances subject to registration in accordance with" REACH; and
(2) All substances not subject to registration under REACH but which
(i) fall within the scope of Article 1 of the CLP Regulation;
(ii) meet the criteria for classification as hazardous; and
(iii) are placed on the market either on their own or in a mixture above the concentration limits specified in the CLP Regulation or the Dangerous Products Directive (1999/45/EC), where relevant, which results in the classification of the mixture as hazardous.
This means that any substance that you import irrespective of quantity that qualifies for notification must be notified by the due date starting on 1 December 2010 – this includes samples imported from out side the EU
3. The CLP Regulation and the CHIP 4 (The Chemical (Hazard Information & Packaging for Supply) Regulations 2009)
The UK CHIP Regulation that enacts the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC) , enforced by the Health & Safety Executive (HSE), needs to be adjusted to align it with the CLP Regulation so that it can be enforced in Great Britain throughout the transitional period and beyond, see HSE web site www.healthandsafetyprofessional.co.uk.
For current obligations and updates to CLP regulations see: http://www.hse.gov.uk/ghs/liveissues.htm
HSE launched a Consultative Document on 19 December 2008 on the proposed CHIP 4 regulations to make the necessary adjustments with a response date of 13 February 2009.
The CHIP 4 Regulations came into force on 6th April 2009.
CHIP 4 provides for a phased transition to CLP as follows:
Substances:
Entry into force 20 January 2009 – 1st December 2010 Suppliers must classify substances according to CHIP, and may continue to label them according to CHIP. However they may label according to CLP, in which case they must classify according to CLP in addition to CHIP. 1st December 2010– 1st June 2015 Suppliers must classify substances according to both CHIP and CLP. They must label according to CLP. 1st June 2015 onwards Suppliers must classify and label according to CLP Mixtures:
Entry into force 20 January 2009 – 1st June 2015 Suppliers must classify mixtures according to CHIP, and may continue to label them according to CHIP. However they may label according to CLP, in which case they must classify according to CLP in addition to CHIP. 1st June 2015 onwards Suppliers must classify and label according to CLP.
The small size derogations for pack sizes of less than 125 mls currently in CHIP remain in CLP.
Child resistant closures – packaging must be sufficiently safe for children . There is specific guidance on this on the ECHA web site at: http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification scroll down to the link to the
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guidance section and follow the links to the 2 guidance documents, and on HSE web site at: http://www.hse.gov.uk/ghs/implications.htm
For a current update on the transition from CHIP 4 to CLP see: http://www.hse.gov.uk/chip/issues.htm
4. CLP and REACH
CLP defines the criteria to be used to classify substances and mixtures as hazardous for the purposes of registration under REACH
REACH requires that Safety Data Sheets (SDS) must be provided if you supply a chemical for professional or industrial use that is classified as hazardous under CLP irrespective of the quantity supplied.
REACH requires that SDS contain the same 16 obligatory headings that are specified in CHIP but in a slightly different order and in most cases require more detailed information to be provided, they must also be consistent with the information provided on the REACH registration dossier and chemical safety assessment.
New requirements for SDS came into force on 1st June 2007 and were reported to the membership.
On 20 May 2010 Commission regulation (EU) No 453/2010 amending Regulation (EC) No 1907/2006 (REACH) was published in the official journal (L333) This amendment updates the Requirement for the Compilation of Safety Data Sheets (SDS) to bring them in line with the requirements of the Globally Harmonised System (GHS) for the classification, labelling and packing of chemicals adopted by EC as the CLP regulations. This regulation retains the 16 categories on the current SDS but changes some of the wording and the arrangement of information in some sections. Members should ensure that they are familiar with these changes since they come into force on 1 December 2010 for substances and on 1 June 2015 for mixtures. The implementation is subject to the phase in conditions where changes can be deferred for up to 2 years for products already on the market on 1 December 2010. Copies of this regulation are available at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:133:0001:0043:en:PDF
See attachments to July 2011 newsletter for examples of SDS format.
The final version of the EC guide to the compilation of safety data sheets was published in September
2011 and can be downloaded at: http://guidance.echa.europa.eu/docs/guidance_document/sds_en.pdf
The first REACH registration deadline was 1 December 2010 (quantities over 1000 Tonnes/yr.) and affected a small number of essential oils in particular sweet orange oil, members may begin to see SDSs with enhanced detail incorporating chemical safety reports and product usage categories as a result. Most of the commonly traded essential oils will be registered in phase 2 (100 – 1000 T/yr.) and 3(1-100 T/yr.), 1 June 2013 and 1 June 2018 respectively and enhanced SDSs will only be generally available when these oils are registered.
Over 60% of the commonly traded essential oils under current estimates (EFEO data) are not subject to REACH i.e. not manufactured or imported in quantities greater than 1 T/yr.
5. Cosmetics Legislation
(a) The Cosmetic Products (Safety) Regulations 2008 came into force on 18 June 2008 revoking and re-enacting the Cosmetic Products (Safety) Regulations 2004. Two amendments have been made since then:
The Cosmetic Products (Safety) Amendment Regulations 2009 dated March 2009 relating to hair dyes and applicable from 14 October 2009;
The Cosmetic Products (Safety)(Amendment No: 2) Regulations 2009 dated June 2009 relating to two hair dye solvents and the maximum authorised levels of Toluene and Diethylene glycol in cosmetic products and applicable from 8 October 2009.
(b) Simplification/Recast of the Cosmetics Directive. Cosmetic products are currently regulated under the European Cosmetic Directive 76/768/EEC, which entered into force in 1976, and has 55 amendments so far.
The new European regulatory framework for cosmetics (EC) Regulation No. 1223/2009 was published in the Official Journal on 22 December 2009 and entered into force on 11 January 2010 with an implementation date of 11 July 2013 (see Members newsletter April 2011) and can be accessed at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
The current Cosmetics Directive 76/768/EEC (as amended) implemented in UK as The Cosmetic Products Safety Regulations 2008 will be repealed on 11 July 2013.
Until 11 July 2013 manufacturers can opt to either continue to comply with the Cosmetics Directive (The Cosmetic Products Safety Regulations 2008 in UK) or to comply with the new regulation.
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This recast involves several changes, including a tighter in-market control, better regulation on cosmetic ingredients, a comprehensive system for product safety assessment and new labelling requirements. One of the major proposed changes is a simplified, centralised and electronic notification system in the European Union.
(c) Efficacy Claims for Essential Oils & Cosmetic Products. Members were reminded that claims for efficacy, or anything else for that matter, must be substantiated. Last year Trading Standards appeared to be taking an interest in non-medicinal claims for essential oils and aromatherapy products, e.g. ‘uplifting’ and one officer had asked if the claim could be proven and what would happen if the customer did not find the product uplifting. This year they have been looking at the advice /warnings on essential oil in relation to its use in pregnancy or not as the case may be. Members are advised to consider the contraindications for the oils they sell to the general public and label accordingly. ASA (Advertising Standards Authority) can and do challenge cosmetic claims made by (major) suppliers, often successfully, Trading Standards police advertising claims in the market place.
(d) Safety Assessments. These are required for all cosmetic products before they are placed on the market and must be made available, on request, to enforcement authorities. Members are reminded that the recast cosmetics directive contains changes to the content and the way safety assessments are formatted see above.
(e) CTPA Guide to Advertising Claims. After three years of discussions, The Cosmetics, Toiletries & Perfumery Association (CTPA), the Advertising Standards Authority (ASA) and Clearcast (an NGO for pre-approving most British television advertising) reached agreement on advertising claims for cosmetics and the evidence required for these. CTPA has prepared new guidelines, the see www.ctpa.org.uk.
(f) COSMOS (The European Cosmetics Organic Standard). After six years of deliberations, the major certification agencies in Europe, including the UK’s Soil Association, have reached an agreement on harmonising their private standards for natural and organic cosmetics. Certification to the new standard was expected to start in September 2009 it was actually launched in February 2011 new organic brands will have to adhere to these new standards. Current organic brands will have a transition period to September 2012 if they need to alter formulations and labelling. But according to industry market research company Organic Monitor, the very fact that it is has taken this long to come to fruition means that other certification bodies, particularly in the US, have already had time to become established.
(g) Animal Testing of Cosmetics. Several updates on this issue have been circulated to members who were reminded in the March 2009 Newsletter of the key strengths of the 7th Amendment to the Cosmetics Directive agreed in 2003. These included:
a ban on the testing of finished cosmetic products on animals in any Member State from 11 March 2005;
a ban on animal testing of ingredients or combinations of ingredients within Member States from 11 March 2009 where non-animal alternatives are available;
a marketing ban on cosmetics containing animal tested ingredients coming into the EU from elsewhere in the world from 11 March 2009;
a total ban on the testing of cosmetic ingredients on animals from 11 March 2013 whether or not non-animal alternatives are available. See March 2011 newsletter for the current position and http://ec.europa.eu/consumers/sectors/cosmetics/animal-testing/index_en.htm and http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm
There is concern that the final ban on the testing of cosmetic ingredients on animals from 11 March 2013 whether or not non-animal alternatives are available will be delayed by the European Commission on the basis that without alternative methods for the remaining toxicological tests there will be a serious public health risk. The EC are required to report to the European Parliament and Council in 2011 on whether the 2013 deadline can be met, the following article in the Guardian sets out the issues http://www.guardian.co.uk/world/2010/dec/31/animal-testing-cosmetics-industry-europe also see http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm for details.
(h) Animal Testing Alternatives. The European Commission launched a new website, TSAR (tracking System for Alternative Test Methods Review Validation & Approval to track the development of new alternative test methods able to refine, reduce and replace current animal testing for products such as cosmetics. Global efforts to promote alternatives to testing on animals received a significant boost through the signing of a cooperation agreement by international bodies and European, American, Japanese and Canadian scientists have agreed to work together to identify scientifically sound alternative testing methods. On 31st August 2009 at the VII World Congress on Alternatives & Animal Use in the Life Sciences in Rome, the European Commission (EC) and the European cosmetic industry presented their joint financial effort for research into alternative safety testing methods. On 30 July 2009 the EC launched a 25 million Euros call for proposals in this field and the European cosmetic industry, represented by the European Cosmetics Association (Colipa),
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committed to match the funds. As a result, up to 50 million Euros will be allocated to research projects laying the scientific foundation for future safety testing methods with a high predictive value and that will be faster and cheaper than animal tests, see www.colipa.eu/statements-list.html?sid=60 (see comments in (g) and links above)
(i) Animal Welfare: The Commission is expected to adopt a Directive designed to boost the welfare of animals that are still used by the cosmetics and other industries for live experiments in the EU. The Directive will make it compulsory to carry out ethical reviews and require that experiments where animals are to be used are subject to prior authorisation by a competent authority. See http://news.bbc.co.uk/1/hi/8619605.stm
(j) Fairtrade Certification for Beauty Products. As of 24 June 2009, UK companies are able to carry the Fairtrade mark for beauty products provided they meet the minimum usage levels of fair trade ingredients for achieving certification: 2% w/w for wash-off products and 5%w/w for leave-on. As of 24 June, 57 beauty products had been licensed by the Fairtrade Foundation which reports that this opens up a new market opportunity for recession-hit producers in developing counties. Producers will get the Fairtrade minimum price plus a premium, a bit extra to invest in community projects such as schools and healthcare. In a recent (2009) survey by Globescan, 31% of the UK population say they want Fairtrade certified cosmetics see www.fairtrade.org.uk so there would seem to be potential for ATC members to benefit from this new market opportunity. For a review of the issues see http://www.personalcaremagazine.com/Story.aspx?Story=6725
6. Traditional Herbal Medicinal Products Directive 2001/83/EC & The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (THMPD).
These UK Regulations came into effect on 30 October 2005 requiring the registration of herbal medicinal products under a simplified registration procedure. They must be able to prove a continuous traditional medicinal use of 30 years, including at least 15 years within the European Community. The 7-year transitional period, ended on 30 April 2011. Products legally on the UK market at 30 April 2004 received transitional protection until 30 April 2011 but after that date, products that have not been registered won't be allowed on-market. We understand that there is a phase-out arrangement where stocks of product on the shelves in shops on 30 April 2011 can still be sold until the end of their shelf life. Details of all current registrations are available on the MHRA’s web site at http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicines/PlacingaherbalmedicineontheUKmarket/TraditionalHerbalMedicinesRegistrationScheme/index.htm. MHRA report that at the 31 March 2011 211 Traditional Herbal Medicine registrations have been received, 101 granted so far covering a total of 76 herbs, none have been refused.
Reform of Section 12(1) of the Medicines Act 1968 under which aromatherapists currently use essential oils as medicines (unlicensed herbal remedies).
7. Reform of Section 12(1) of the Medicines Act
If S12(1) is removed then it seems to us that only professional aromatherapists that are suitably trained to the National Occupational Standards, that are members of a professional association and subject to professional codes of conduct etc., will be able to use their skills to mix treatment blends and blends for home use for their clients as set out in the National Occupational Standards without requiring them to be safety assessed by an independent
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safety assessor - aromatherapists of course make their own safety assessment of the products they use and supply - but they will not be able to make any medicinal claims for them.
Current position
The current position on the reform of Section 12(1) and the provision of unlicensed herbal remedies is available on the MHRA website as follows: http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicines/PlacingaherbalmedicineontheUKmarket/Unlicensedherbalremediesindividualpatients/index.htm and is reproduced in part here:
Current requirements
Section 12(1) is commonly referred to as the 'herbalist exemption' and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual patient following a one-to-one consultation.
The existence of this regime is greatly valued by herbal practitioners and by many members of the public. However, there are widely acknowledged weaknesses in the public health protection given by the regime.
Section 12(1) remedies are not subject to a regime of specific safety or quality requirements. There are no restrictions in terms of those who operate under the regime. Anyone - irrespective of qualifications or experience - can practise herbal medicine and, after making a diagnosis and forming a judgment about the treatment required, can make up and supply an unlicensed herbal medicine.
Proposals for reform
Proposals for reform of Section 12 (1) are being developed alongside the DH led work on regulation of the herbal medicine profession.
On 16 February 2011, a DH announcement was made about regulation of practitioners (external link).
The Health Professions Council (HPC) will establish a statutory register for practitioners supplying unlicensed herbal medicines. Registration of practitioners will be underpinned by strengthened medicines legislation. The
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announcement follows the DH consultation exercise which was launched on 3 August 2009 on whether practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be regulated.
See also section (8) below
8. The Department of Health Joint Consultation on the Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems practised in the UK
The current position is available on the MHRA website as follows: http://www.mhra.gov.uk/NewsCentre/CON108789 and is reproduced in part here:
News
18 February 2011
The Secretary of State for Health has made an announcement today about regulation of herbal medicine practitioners. The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords Select Committee report on Complementary and Alternative Medicine in 2000.
The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients.
Accordingly, a scheme would be created enabling registered practitioners to commission unlicensed herbal medicines to meet the special needs of their individual patients. Safeguards for the public would be provided by a combination of professional regulation and linked medicines regulation, for example, to safeguard manufacturing standards.
If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.
A formal consultation exercise will take place on specific legislative proposals for establishing the register and proposed reforms of medicines legislation later in 2011.
Further information is published on the Department of Health's website:
For the Healthcare Professions Council (HPC) position see: http://www.hpc-uk.org/mediaandevents/statements/herbalistandtraditionalchinesemedicinepractitioners/ and reproduced in part here:
HPC Position on the statutory regulation of Herbalist and Traditional Chinese Medicine practitioners
On 16 February 2011 the Government published a Command Paper on regulation called 'Enabling excellence' which announced the Government‟s proposals for the regulation of healthcare workers across the UK and social workers in England.
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The Command paper sets out the Government‟s intentions for the regulation of herbal medicine practitioners and traditional Chinese medicine practitioners, and other practitioners who use unlicensed herbs within their practice.
This follows the implementation of the European legislation—Directive 2004/24/EC on Traditional Herbal Medicinal Products, that recently came into force (April 2011). The Directive requires manufactured herbal
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medicines to be licensed in the same way as conventional medicines. Under the legislation the only exemption from this is if a practitioner is regulated.
The Command Paper acknowledges the HPC is an established and experienced regulator and recommends we create a statutory register for practitioners supplying unlicensed herbal medicines.
The Paper does not go into detail about how these groups will be regulated but does say that the focus of regulation will be „solely on minimising risk to the public‟. The register will be a register of people who are able to dispense unlicensed herbal medicines. The exact form and scope of that regulation is currently unclear until the four UK Government health Departments publish a consultation on the necessary legislation. This is anticipated later this year.
The HPC will work with the Governments and other stakeholders on the proposals to enhance public protection.
Further information will be posted on the HPC website when it is clearer how these practitioners will be regulated.
For further info on aspirant groups please see below:
http://www.hpc-uk.org/aboutregistration/aspirantgroups/
See also section (7) above
The current position of the statutory regulation of acupuncturists is to be found at: http://www.acupuncture.org.uk/about-us/statutory-regulation.html
As we understand it there is no plan to extend statutory regulation to acupuncturists.
9. Biocides – Competent Authority for the Regulation of Pesticides, Biocides, Detergents & Industrial Chemicals
The Health & Safety Executive (HSE) regularly places bulletins on their web site at www.hse.gov.uk/biocides and there are currently several new ones interested members should consult the website for details on a regular basis.
HSE wrote to all its stakeholders to announce that a new Directorate, the Chemicals Regulation Directorate (CRD) had been created on 1st April 2009. The CRD is a Directorate of the HSE and its major role is to deliver Competent Authority functions within EU legislation regulating chemicals, pesticides, biocides and detergents where HSE is the appointed authority for the UK. The principal programmes covered are:
The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation;
The Biocidal Products Directive (BPD); and also ongoing regulatory responsibilities under the UK Control of Pesticides Regulations (CoPR);
Plant Protection Products Directives and Regulations;
Detergents Regulations;
EU Classification, Labelling and Packaging Regulation
The Biocidal Products Directive is due to be turned into a Regulation in 2013 and will be directly applicable in all Member States. Currently the UK HSE has confirmed that a product cannot be both a biocide and a cosmetic product and that if the primary function of a product is as a cosmetic, subject to the Cosmetic Products Directive, then a secondary function for biocidal effect could be made. However this is not the position in other EU states and is not the current view of the EC. We will need to keep an eye on the UK situation when the BPD becomes a directly-acting Regulation. The current position can be found at: http://www.hse.gov.uk/biocides/bpd/transposition.htm
10. MHRA Consultation Documents.
We continue to receive notification of Consultation Documents from the MHRA on amendments to Medicines Regulations, most of which do not affect ATC members. Progress of the MHRA’s Concept Paper published in January 2009 on their project to consolidate and review UK Medicines Legislation and how this might affect the Reform of S12(1) has been reported in (7) and (8) above.
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11. European Federation of Essential Oils (EFEO).
As reported at the 2009 AGM we have terminated our membership of EFEO
13. European Commission’s Directorate General Enterprise & Industry/Department for Business, Innovation & Skills (BIS)
We receive regular e-news copies of Enterprise News from the Commission updating us on current EC news and monthly Consumer News Bulletins giving us the latest developments in UK consumer policy from BIS.
14. IFRA Standards Booklet
The 45th amendment to the IFRA Standards booklet was issued on 11 February 2011 and is available at: http://www.ifraorg.org/en-us/standards_booklet
15. Nanotechnology
Nanotechnology and cosmetic ingredients is becoming a hot issue and this is reflected in the requirement in the Cosmetics regulations (EC) 1223/2009 (the recast cosmetics directive) to label nano-ingredients separately in the list of ingredients and in the proliferation of scientific papers on the safety of cosmetic ingredients in nano-particulate form and the recently published ISO standard. See March newsletter on Personal care products for detail and http://www.cosmeticsdesign-europe.com/On-your-radar/Nanotechnology for a comprehensive review of the issues.
16. Parabens
proposed restrictions on some parabens in cosmetics. Denmark has now unilaterally banned some parabens in products for children under 3years, see the following for details: http://register.consilium.europa.eu/pdf/en/11/st07/st07428.en11.pdf
17. Unsaturated vegetable oils and Spontaneous combustion
A report of a fire attributed to spontaneous combustion of grape seed oil on cotton towels was reported . Vegetable oils are often considered to be non-hazardous and their properties as a combustible liquid are often over looked members should bear in mind that animal and vegetable oils, fats and waxes are frequently highly unsaturated and as such subject to oxidation that can under very specific circumstances spontaneously combust and should be described on SDS accordingly.
Essentia
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