Guidelines For Control Of Cosmetic Products In Malaysia

Who should notify the authority?

All cosmetic products must be notified with the NPRA before it can be marketed in Malaysia . A foreign company wishing to bring cosmetic products into Malaysia would first have to appoint a local agent (a company registered in Malaysia ) to be the holder. The appointed agent would then be responsible for all matters pertaining to the notification of the products.

The company or person responsible for placing a cosmetic product in the market is responsible for notifying the Director DPS prior to manufacture, import, supply by wholesale or sale of the products. A letter of authorization (LOA)  from the product brand owner is required if the company or person notifying does not own the product. The company must be registered with Syarikat Suruhanjaya Malaysia (SSM) or Malaysian Registrar of Business (ROB). 

Determine the category of your product is COSMETIC or MEDICAL DEVICE DRUG COSMETIC INTERPHASE (MDDCI) PRODUCTS. Refer to GUIDANCE FOR THE CLASSIFICATION OF MEDICAL DEVICE-DRUG-COSMETIC INTERPHASE (MDDCI) PRODUCTS

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CNH must ensure compliance to the following requirements prior to notification submission.

3.1 Product Particulars 

3.1 Product Particulars

CNH is required to submit the following information during the notification process:

  3.1.1 Particulars of product including product name, product type, intended use and product presentation
  3.1.2 Name and address of the manufacturer(s) and assembler(s), if any
  3.1.3 Name, address and valid contact number (and e-mail address) of the CNH
  3.1.4 Particulars of person representing the company of CNH including valid contact number
  3.1.5 Name and address of the importer(s), if any
  3.1.6 Full product ingredient list (the content i.e. percentage (%) of the restricted ingredients must be declared)
  3.1.7 Letter of Authorisation/Letter of Declaration/Letter of Contract Manufacturing, where applicable
  3.1.8 Label(s) of the product

3.2 Safety Requirements 

The provisions of Article 3 of the ASEAN Cosmetic Directive stipulates that “A cosmetic product put on the market must not cause damage to the human health when applied under normal or reasonably foreseeable condition of use taking into account in particular of the product presentation, its labelling, instruction for its use and disposal warning statements as well as any other information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the market.”

Hence cosmetic products have to be safe both for consumers and, if relevant, for involved professionals (e.g. hairdressers, beauticians, etc.).

As far as skin is concerned, the two main untoward reactions to be avoided are skin irritation and skin sensitisation2. Cosmetic products are often applied on areas exposed to environmental factors. Thus, care has also to be taken to avoid photo-induced reactions such as photoirritation and photosensitisation.

Products applied on the scalp or the face may come in contact with the eye. Consequently, eye tolerance has to be addressed with optimal attention as a major component of the safety assessment for a cosmetic product. Systemic toxicity that may result from percutaneous absorption or from accidental (children) or reasonably foreseeable (e.g. oral hygiene products, lipsticks) oral intake should also be considered. Ensuring the safety of a cosmetic product requires a global approach throughout the life of the product from the choice of raw materials to the marketing follow-up. A number of issues have to be taken into account, including: • Applying Cosmetic Good Manufacturing Practice Guidelines or approved equivalent • Careful selection of cosmetic ingredients, making sure that they will be safe at a given concentration in a given finished product • Checking local tolerance of the finished product • Selection of adequate packaging to maintain the quality of the product and to avoid, as far as possible, risks of misuse or accident • Quality control, mainly microbiological and chemical • Stability studies e.g. to evaluate shelf life, preservative effectiveness (challenge test), compatibility of the product and the packaging, etc. • Appropriate labelling - presentation of the product, instructions for use and disposal, warnings (if relevant) and appropriate action to take in case of accident • Adequate procedures in case of side effects with  the  marketed product -  caseby-case treatment, appropriate medical, dermatological, ophthalmological etc., advice as necessary, follow-up of the product on the market and consumer comments, information storing etc. In case of Serious Adverse Event, the procedure must be identical to the Guide Manual for Adverse Event Reporting • Ensuring corrective action/ follow-up, if any visible product change or adulteration is advised from the market place Although it is not possible to attain zero risk or to obtain absolute safety in any kind of human activity, including cosmetology, reasonable efforts have to be made to reduce the risk from cosmetic products to the minimum, according to the state of the art at the time. There is no formalistic approach to the safety evaluation process. The actual process will vary from product to product according to the novelty of the product composition and to the relevance and adequacy of information available. However, as a general rule, the major basis for safety evaluation is provided by considering the toxicological profile of its ingredients.

From a scientific point of view, in almost all cases finished product testing does not require the use of toxicological tests in animals. In general, all questions which are posed at this stage can be answered by utilising other information sources, including human data from skin compatibility tests ethically performed on the skin of human volunteers4.

1.INGREDIENTS

Cosmetic ingredients are mostly chemicals and often mixtures of chemicals of synthetic origin or natural extracts. The careful selection of ingredients is the key issue for ensuring the safety of the finished product.

The structure of the chemical determines its chemical and biological reactivity e.g., Barratt, 19555. This has to be considered from two points of view: cosmetic interest and safety. Other considerations are the degree of chemical purity, the possible interactions with other ingredients in the formulation and potentiation of skin penetration. In general, the presence of impurities is technically unavoidable. But these impurities have to be of no significant toxicological relevance in the finished product. Particular attention should be taken to the possibility of interaction between impurities (e.g. formation of nitrosamines) and the presence of pesticide residues, toxic metals and/or transmissible spongiform encephalopathies (TSE) in ingredients of botanical origin or extracted from animals.

Based on the state of knowledge, possible interactions between ingredients with potential safety relevance have to be considered. Influence on skin penetration may also be of importance, especially for sensitisation and systemic risks6. Skin penetration can be assessed using in vitro methods 6. Determination of allergic potential may also require testing of ingredients formulated with suitable vehicles.

On the other hand, the safety-in-use of an ingredient largely depends on the exposure conditions (type of formulation, concentration, frequency and duration of contact, body area involved, effect of the sun, etc.) taking into account normal conditions of use and foreseeable misuse.

1.1Ingredients to Be Avoided

For each raw material, it is necessary to check whether it is covered by current legislation and, if so, whether the proposed usage is within the prescribed parameters. The following ingredients must be excluded:

• Prohibited ingredients listed in Annex II

• Restricted ingredients restricted when used beyond the allowed conditions and restrictions laid down in Annex III

• Ingredients with toxicological data incompatible with the intended concentration and use

• Ingredients which do not have sufficient toxicological data and/or safety in use experience

• Ingredients which are not properly characterized either chemically or through the extraction process for natural extracts

• For colouring agents, preservatives and/or UV filters, ingredients must be substances listed in Annexes IV, VI or VII respectively, within the limits and under the restrictions laid down in these annexes

Data to be taken into consideration, besides those directly relating to toxicity, include positive identification of the ingredient, potential impurities of relevance, physico-chemical properties and analytical chemistry, potential interaction with other ingredients of the formulation and possible role in skin penetration.

The toxicological profile of a raw material is obtained by analysing available data, published or not, concerning the raw material. These data may include results of in vitro, in vivo and clinical testing, as well as results of epidemiological studies where available. It is clear that new ingredients or ingredients used in a novel application require particular attention.

1.2Sources of Toxicological Data

The main sources of toxicological data on ingredients are from the suppliers. Raw material manufacturers have to comply with national legislation on chemicals/dangerous substances (occupational safety, transport, packaging and labelling).

Most effort should be made to collect toxicological data and other relevant information from the suppliers. It may be necessary to encourage the supplier to conduct additional studies. As these data can be needed for regulatory purposes other than the Cosmetics Directive, the use of alternative (non-animal) test methods is restricted to those which are generally accepted (e.g. OECD guidelines).

Other sources of toxicological data may be obtained from:

• Scientific literature, databases (e.g. Toxline, Medline), reports issued by the US Cosmetic Ingredient Review (CIR) program, the EU Scientific Committee on Consumer Products (SCCP) or the ASEAN Cosmetic Scientific Body (ACSB), the Research Institute for Fragrance Materials (RIFM) monographs, reports by ECETOC, NTP, BIBRA, etc.

• Safety Data Sheets

• In-house experience with the particular ingredient and cosmetic products containing it

• Expert judgment based on similarities with chemically related substances

Ingredients listed in Annexes III to VII of the Guideline for the Control of Cosmetic Products in Malaysia do not need supporting evidence provided that they are used as specified in the Annexes. In the case of substances in Annex VI in which concentrations higher than those specified may be used for other functions, supporting information is likely to be necessary.

The composition of fragrances and flavours is generally not available to the cosmetic manufacturer and use should be made of the safety evaluation as well as conformity to the latest International Fragrance Association (IFRA) Guidelines which have to be provided by the supplier 7.

1.3Conditions of Use and Exposure

Evaluation of the safety of ingredients is certainly not adequate as a stand-alone procedure but has to include considerations of exposure (magnitude, route, duration, frequency, etc.)3.

The following parameters have to be considered8:

• Class of cosmetic product(s) in which the ingredient is used

• Method of application (e.g. rubbed-in, sprayed, applied and washed off, etc.)

• Concentration of ingredient in product

• Quantity of product used for each application

• Frequency of application

• Total area of skin contact

• Site of contact (e.g. mucous membrane, sunburnt skin)

• Duration of contact (e.g. rinse-off products, leave-on products)

• Reasonably foreseeable misuse which may increase exposure

• Type of consumers (e.g. children, people with sensitive skin)

• Projected number of consumers

• Application to skin areas exposed to sunlight

• Quantity likely to enter the body

This last point, which relates to systemic availability, is a critical issue in safety evaluation

- the information is mainly provided by percutaneous absorption data.

2.SAFETY EVALUATION OF FINISHED PRODUCTS

The assessment of the safety of any cosmetic product clearly relates to the manner of use. This factor is most important since it determines the amount of substance which may be absorbed through the skin or mucous membranes, or ingested or inhaled.

As mentioned above, the main sources of information are the toxicological characteristics of ingredients and the available human experience (including market experience, beauticians, factory workers, etc.) with similarly composed products. Each ingredient has to be considered carefully. Particular attention should be paid to new and novel ingredients. Open questions of safety assessment are defined by expert judgment in each individual case after careful review of all available information.

In general, the potential of a cosmetic product for sensitisation, genotoxicity and all other types of systemic (toxic) effects will be evaluated on the basis of the properties of the ingredients. Adequate consideration of human exposure is, however, of paramount importance for the interpretation of available data. This involves an examination of the potential role of the vehicle. This holds particularly true for percutaneous absorption or quantitative data concerning any other route of entry into the systemic circulation. The question of possible interaction between different ingredients will usually be evaluated on the basis of experience (similarities, published data on related compounds/mixtures, theoretical considerations, etc.) and may be controlled using in vitro testing and/or skin compatibility tests.

For assessing the safety-in-use of a finished product, especially the local tolerance, it can be very useful to compare it with other formulae successfully marketed by the company.

If the new product is a simple variant of an existing product, or if the formulation only consists of raw materials or ingredients previously used in similar products at common use levels, then it is likely that no additional safety data will be needed.

If raw materials are used in new ways, then additional safety data may be required by the safety assessor.

If novel raw materials or raw materials new to the company are to be used, then more detailed information will be necessary.

Local tolerance largely depends on the whole formulation. Consequently, even with known and safe in- use ingredients, it may be necessary to check the skin compatibility of a new formulation by appropriate testing.

When exhaustive analysis of toxicological data on ingredients appears insufficient to define with certainty the local tolerance of the finished product, additional experiments can be performed in vitro and/or in human volunteers.

In vitro testing may be carried out to complement available information with the necessary use of appropriate benchmarks. For ocular safety, methods such as those listed below are available:

• BCOP - Bovine Cornea Opacity and Permeability Test

• FLT or TEP - Fluorescein Leakage Test or Trans Epithelial Permeability

• HET-CAM - Hen’s Egg Test - Chorioallantoic Membrane

• RBC - Red Blood Cell Test

• TEA - Tissue Equivalent Assay

Skin compatibility or tolerance may be checked using reconstructed skin models and/or ethically conducted trials on human volunteers.

Clinical trials in man should be based on the principles of Good Clinical Practice (GCP). The following type of tests may be performed:

• Open epicutaneous application (single or repeated)

• Closed epicutaneous application (single or repeated)

• Controlled application tests

• Further testing may involve in-use tests and /or market tests

3.SAFETY CLAIMS

If a safety claim is to be made, e.g., “dermatologically tested”, it has to be supported by adequate evidence. In most cases, appropriate human testing on the finished product will be necessary rather than animal testing. The testing must meet all necessary ethical requirements for a clinical trial 9; 10. One important prerogative in this respect is the safety assessment by a suitably qualified and experienced person before the trial starts4.

4.RESPONSIBILITIES OF THE SAFETY ASSESSOR

The person in charge of assessing the safety of the product is called the safety assessor. The safety assessor is responsible for determining:

• Whether or not the ingredients present in the formula meet the requirements of the legislation in respect of the concentration for authorised substances, absence of substances prohibited by the law and, more generally, in respect of all legal requirements

• Whether or not particular endpoint(s) have to be considered for a given ingredient

• Whether the data available are relevant and sufficient

• Whether or not interactions of toxicological relevance and/or modifications to penetration are likely to occur

• Whether or not complementary data are needed either on ingredients or on the finished product

A modern approach to safety assessment is based on a thorough analysis of available data and conditions of exposure. Ideally, the development of the formulation should take into account these elements from the start by a close collaboration between safety assessor and formulator.

A proper choice of ingredient at an adequate concentration level is sufficient to avoid the major risks (e.g. genotoxicity, carcinogenicity, systemic toxicity) and also to avoid, to a large degree, sensitisation. Testing on finished products is unnecessary in most cases to assess these risks, provided potential interactions between ingredients and role of vehicle are considered. In most cases, the knowledge of all information available is sufficient to assess the safety of finished products. In the case of totally new ingredients, new combinations of ingredients or new formulation processes without safety-in-use experience, additional testing may be needed. However, in all cases, all information on ingredients and formulations should be made accessible by the suppliers and formulator to the safety assessor to ensure an adequate safety assessment.

The Safety Assessor should possess qualification in relevant fields for example a diploma in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline and be suitably trained in the safety assessment of cosmetics.

The role and responsibility of the safety assessor have to be emphasised. It is in the interest of the company to select a person knowledgeable in the field of safety evaluation applied to cosmetics and who is responsible and ethical.

The Safety Assessor does not need to be an employee of the company and can belong to an external organization or institution, as long as he has the required qualification.

The safety assessor must:

• Have recognised competence and ethics in the field

• Have access to both the toxicological and analytical information pertinent from a safety view point. Some questions are likely to be raised by the safety assessor concerning, e.g. purity of raw materials, impurity profile - if available, and control procedures applied, detailed information on a test mentioned or referred to by the supplier, quantitative analysis of an impurity with a potential toxicological relevance, etc.

• Not be involved with the commercial aspects related to the product

Safety assessment may require human testing to check skin compatibility of both cosmetic ingredients and finished products. Any such trials have to be carried out following the appropriate ethical requirements 9; 10.

The judgment of the safety assessor relies on:

• The knowledge and experience of toxicological properties and safety-in-use of the known ingredients

• The history of safety-in-use of products containing the same or similar ingredients

• The expert judgment of the set of data available on an unknown, new or novel ingredient

• If necessary, the results of additional data obtained either on one or more ingredients or on the finished product

The safety assessor may conclude:

• The product is safe as such without special warnings or precautions

• The product is safe provided a given type of packaging is used or provided a warning is added or the mode of use and usage instructions are defined more precisely or provided a complementary test with favourable results is performed

• The product is not safe for the proposed use

• That available data are not sufficient to determine whether or not the product will be safe and that further studies need to be carried out to obtain the required information

• Specific safety claim(s) may or may not be used

A product cannot be marketed if the conclusion of the safety assessor is that the product may not be marketed safely under the normal or reasonably foreseeable conditions of use. Recommendations by the safety assessor which are relevant for the safety-in-use of the product have to be followed. They are part of the safety statement the assessor signs which should be presented, together with the qualifications of the safety assessor, to the relevant regulatory authorities (inspectors) when required.

Selecting the safety assessor thus appears to be a key issue for the manufacturer of cosmetic products. It is not only a legal issue: it may also have importance for other aspects such as, for example, the image of the company as well as product liability implications.

5.RAW MATERIAL SUPPLIER RESPONSIBILITIES

1. Chemicals

Provide its customers with adequate information as to the safety of the ingredients supplied:

• Physical/chemical/microbiological specifications-purity

• Absence of Annex II ingredients beyond unavoidable traces (e.g. heavy metals)

• Toxicity studies:

  • Acute toxicity

  • Dermal absorption

  • Skin (and eye) irritation

  • Mucous membrane irritation (if necessary)

  • Skin sensitisation

  • Sub-chronic toxicity

  • Mutagenicity

  • Photo toxicity and photo mutagenicity (if necessary)

  • Human data (if available)

5.2Botanicals Extracts

Provide its customers with adequate information as to the safety of the ingredients supplied:

• Proper identification of the plant/part used

• Physical/chemical/microbiological specifications-purity

• Pesticide level

• Absence of Annex II ingredients beyond unavoidable traces (e.g. heavy metals)

• Toxicity studies:

  • Skin irritation – sensitisation

  • Photo toxicity – photo sensitisation (if necessary)

  • Mutagenicity

5.3Animal Extracts

Provide its customers with adequate information as to the safety of the ingredients supplied:

• Proper identification of the animal/part used

• Physical/chemical/microbiological specifications-purity

• Absence of Transmissible Spongiform Encephalopathy

• Absence of Annex II ingredients beyond unavoidable traces (e.g. hormones, antibiotics, etc.)

• Toxicity studies:

• Skin irritation – sensitisation

• Photo toxicity – photo sensitisation (if necessary)

• Mutagenicity

5.4Fragrances and flavours

Provide its customers with adequate information as to the safety of the fragrances supplied:

• Certificate of compliance with latest IFRA Guidelines

• Maximum safe concentration depending on the product type

6.MANUFACTURER RESPONSIBILITIES

Includes:

• Careful selection of cosmetic ingredients, making sure they will be safe at a given concentration in a given finished product

• Checking local tolerance of the finished product

• Selecting adequate packaging to maintain the quality of the product and to avoid, as far as possible, risks of misuse or accident

• Applying ASEAN Cosmetic Good Manufacturing Practices

• Quality control, mainly microbiological and chemical

• Appropriate labelling: presentation of the product, instruction for use and disposal, warnings (if relevant) and appropriate actions to take in case of accident

• Adequate procedures in case of side effects with the marketed product.

• Ensuring corrective action, follow-up if visible product change or adulteration, is advised from the market place

• Proper selection of the Safety Assessor

7.DISTRIBUTOR RESPONSIBILITIES

Includes:

• Making sure the manufacturer has the adequate systems to ensure product safety (including GMP)

• Collecting information from post marketing experience and transferring such information to the manufacturer on a timely basis, determining trends and keeping adequate records

• Reporting any Serious Adverse Event to the Authorities.

8.REGULATOR RESPONSIBILITIES

Includes:

• Ensuring public health and safety

• Auditing products in the market

• Auditing the Product Information File (PIF)

• Inspection of company premises

• In the case of serious adverse events, collaborating with the Industry to take proper action

• In the case of product test results showing potential risk to human health or an adulterated product, taking appropriate measures to remove the product from the market, communicating with the public and taking appropriate action towards the responsible company/person

3.3 Cosmetic Ingredients

i) Marketing of cosmetic product(s) containing the following ingredients is prohibited:

   3.3.1 Substances listed in Poisons List (unless exempted); Poison Act 1952.
   3.3.2 Substances listed in Annex II
   3.3.3 Substances listed in Annex III which are used beyond the specified limits and outside the conditions laid down.
   3.3.4 Colouring agents other than those listed in Annex IV with the exception of cosmetic products containing colouring agents intended solely for hair colouring.
   3.3.5 Colouring agents listed in Annex IV which are used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to for hair colouring.
   3.3.6 Preservatives other than those listed in Annex VI
   3.3.7 Preservatives listed in Annex VI which are used beyond the specified limits and outside the stated conditions laid down therein, unless other concentrations                       are used for specific purposes apparent from the presentation of the product.
   3.3.8 UV filters other than those listed in Annex VII
   3.3.9 UV filters listed in Annex VII which are used beyond the limits and stated outside the conditions laid down therein.

ii) The presence of traces of substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms to safety requirements.

3.4 Labelling Requirements

CNH shall ensure that the label of cosmetic product complies with the labelling requirements as defined in Annex I, part 7: Cosmetic Labelling Requirements. The information on the label shall be in Bahasa Malaysia and/or English.

Halal logo may be used voluntarily on a notified cosmetic product, for both the local and export markets, provided that the product has been certified and approved Halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM) or any Islamic Body recognised by JAKIM.

3.5 Cosmetic Claims 

As a general rule, claimed benefits of a cosmetic product shall be justified by substantial evidence and/or by the cosmetic formulation or preparation itself. The CNH shall provide scientifically accepted protocols or study designs in generating the technical or clinical data with justification.

A cosmetic product should not use a name and claims that are regarded as medicinal in nature or beyond the cosmetic scope.

A guidance document on cosmetic claim including some examples of non-permissible claims is available in Annex I, part 8 : Guideline for Cosmetic Claims.

For specific guidance regarding sunscreen products/claims, please refer to Annex I, part 9(i) : Guideline for Sunscreen Product.

For specific guidance regarding hand sanitizers, please refer to Annex I, part 9(ii) : Guideline for Hand Sanitizer Product

For specific guidance regarding antibacterial hygiene wash products/claims, please refer to Annex I, part 9(iii) : Guideline for Antibacterial Hygiene Wash Product

It is prudent for CNH to seek legal or expert advice to ensure that the proposed claims do not breach existing Acts or Regulations

3.6 Cosmetic Advertisement

1.     PROHIBITION

Advertisement should not refer to any medicinal claim or claim which is beyond the scope of cosmetic product. All claims whether being described either in written, pictorial, verbal statement or in any other mode purported to deliver such claim shall comply with the Annex I, Part 8: Cosmetic Claims Guideline. 

Advertisements include any notice, circular, report, commentary, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound.  “advertisement” means every form of advertising (whether or not accompanied by or in association with spoken or written words or other writing or sounds and whether or not contained or issued in a publication) by the display of notices or by means of catalogues, price lists, circulars, labels, cards or other documents or materials or by the exhibition of films or of pictures of photographs, or by means of radio or televisions, or in any other way including through electronic means. “Electronic” means the technology of utilizing the electrical, optical, magnetic, electromagnetic, biometric, photonic or other similar technology. 

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1.1Impressions of Professional Advice or Endorsement

1. Advertisements should not:

1. Have any visual and/or audio presentation of individual(s) e.g. doctors, dentists, pharmacists with the impression of giving professional recommendation or endorsement; or

1. Contain statements giving the impression of professional by endorsement, advice or recommendation made by associations or persons who appear in the advertisements and who are presented directly or by implication, as being qualified to give such endorsement, advice or recommendation e.g. the use of white coat, stethoscope, healthcare professional environment/ any expression that provides undue authority that the product is recommended by a healthcare professional

1. Advertisement may contain statements that are concluded from unbiased/ objective surveys/information, genuinely obtained from professionals. Care shall be taken, that the statements do not transgress any relevant regulations that the professionals institution to which they belong

Endorsement by professional bodies may be allowed with the consent from the respective professional bodies. Authorization from said bodies should be given in writing and produced upon demand.

Advertisement shall not refer to a ‘hospital’ or similar establishment.

It is important to note that registered healthcare professionals are governed by ethics of the relevant statutory body that grants the respective registration and personal involvement in such promotion may lead to breach of ethics.

1.2Standard of Morality or Decency

Advertisements should not contain statements or visual presentation which are, or likely to be interpreted to be contrary or offensive to the standard of morality or decency prevailing in the Malaysian society or in any way defamatory or humiliating to any segment of the public.

1.3Honesty or Truthful Presentation

1. Advertisements should not be so framed as to abuse the trust of the consumer or exploit his/her lack of experience or knowledge.

1. All descriptions, claims and comparisons which relate to matters of objectively ascertainable fact should be capable of substantiation, and should be held ready for immediate production upon request by the authority.

1.4Fear, Superstition, Religious

Advertisement should not:

1. Play on fear without justifiable reason. Advertisements should not contain any statement or illustration likely to induce fear on the part of the viewer or listener that he is suffering and without the use of the cosmetic product may worsen the condition.

1. Play on superstition or exploit superstitions. Advertisements should not contain any presentation or reference to mythical object or supernatural beings or powers.

1. Directly or by implication exploit the religious requirements/beliefs of any community.

1.5Acts of Violence or Illegal Activities

Advertisement should not contain anything which might lead or lend support to acts of violence, criminal or illegal activities, nor should they appear to condone such activities.

1.6Dangerous Practices or Disregard for Safety

Advertisement should not, without justifiable reason, show or refer to dangerous practices or manifest a disregard for safety. Special care should be taken in advertisements directed towards or depicting children or young people.

1.7Children and Young People

Advertisements addressed to infant, children or young people or likely to be seen by them, shall not contain anything whether an illustration or otherwise, which result in harming them physically, mentally or morally or which exploit their credulity, natural sense of loyalty or their lack of experience.

1.8Imitation

1. Advertisements shall not be similar in general layout, copy, slogans, visual presentation, music or sound effects to other advertisement as to likely mislead or confuse.

1. Particular care shall be taken in the packaging and labelling of goods to avoid causing confusion with competing products.

2.COMPARISON

2.1Disparagement and Denigration

1. Direct comparison advertisements against competitors' products or service are strictly not allowed.

1. Comparison advertising may be permitted provided it does not use symbols, slogans, titles, or statements that are clearly identified or directly associated with competitive brands. Competitive claims inviting comparison with a group of products or with other products categories (without identifying any specific brands) may be allowed provided these are adequately substantiated.

1. Advertisements should not directly or indirectly disparage, ridicule or unfairly attack competitors, competing products or services including distinguishing feature of their advertising campaigns such as specific layout, copy, slogan, visual presentation, music/jingle or sound effects.

1. Advertisement shall not contain any statement which either expressly, or by implication disparage any profession, product, services or advertisers in an unfair or misleading way.

2.2Before and After Effects

1. "Before" and "after" situation must reflect truthful and factual comparisons. Comparisons of the "antecedent" situation with the "subsequent" situation must not be exaggerated or misleading.

1. Advertising comparing "before" and "after" situations should cite with prominence the specific time elapsed between the two situations.

3.TESTIMONIAL

Advertisements shall not contain or refer to any testimonial or endorsement unless it is genuine and related to the personal experience over a reasonable period or time of the person giving it. Testimonials or endorsements which are obsolete or otherwise no longer applicable, (e.g. where there has been a significant change in formulation of the product concerned) shall not be used.

Advertisement with a testimonial is suggested to include this statement: ‘The effects of the product may vary among individuals’

4.TEST, TRIALS AND RESEARCH

1. Reference expressly or by implication to test, trials, research and the likely may only be used if they are fully substantiated and not misleading. References to tests or trials conducted in a named hospital, clinic, institute, laboratory or college or by named professional or official organization are permissible only if authorized, approved and found acceptable by the authority of the institution or organization concerned.

1. Test, trial and research in supporting medicinal claims are not allowed to be used in the advertisement.

5.HYPERBOLE WORDS/SUPERLATIVE/CLAIMS

1. All claims in the advertisement should be substantiated and readily available when being challenged by authority or competitors.

1. Advertisement may contain hyperbole words or superlative or claims only when it can be substantiated when challenge.

3.7 Good Manufacturing Practice (GMP)

All cosmetic products must be manufactured in accordance to the Guidelines for Cosmetic Good Manufacturing Practice or its equivalent. For details, please refer to Annex I, part 11: Guideline for Cosmetic Good Manufacturing Practice (GMP) and Annex I, part 12: List of Equivalent Cosmetic GMP Guidelines.

A new local manufacturer/ new production line shall be inspected by NPRA prior to cosmetics notification. The manufacturer needs to ensure that the layout of the manufacturing facility is designed and planned according to GMP principles. Please refer to the Frequently Asked Questions (FAQs) related to GMP inspection, which is available in NPRA website.

Following from that, all local manufacturers are subjected to periodical regulatory GMP inspection to ensure continuous compliance.

For foreign manufacturers, documentation to prove GMP compliance is to be made available upon request by the NPRA. Document/declaration of compliance to cosmetic GMP (or equivalent) must be issued/endorsed by authorised body/agency at country of manufacturer.

3.8 Product Information File (PIF

CNH shall be responsible for providing all information, certificates/documents and data requested by the NPRA. The PIF can be either in the form of a “dossier” (i.e. an extensive collection of paper records stored in a specific location) or in electronic format (i.e. soft copy). It should be readily available and accessible upon request by the NPRA.

The PIF shall be in Bahasa Malaysia or English.

The PIF shall be kept updated for all changes made to the notified product such as new ingredients, manufacturers, raw material suppliers and production process. Date of document revision, where appropriate shall be stated for verification.

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Below is the list of information required in the PIF:

1. The qualitative and quantitative composition of the product, in case of perfume compositions, the name and code number of the composition and the identity of the supplier

1. Specifications of the raw materials and finished product

1. The method of manufacture complying with the good manufacturing practice as laid down in the Guideline for Cosmetic Good Manufacturing Practice

1. Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure

1. Existing data on undesirable effects on human health resulting from use of the cosmetic product

1. Supporting data for claimed benefits of cosmetic products should be made available; to justify the nature of its effect

The CNH is also required to provide information on the method of analysis to the regulatory authority:

1. The available methods used by the manufacturer to check the ingredients of cosmetic products corresponding with the Certificate of Analysis

1. The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria.

1.2Recommended PIF format

The CNH needs to organize the PIF in such a way that it meets the stipulated requirements and easily consulted by the NPRA. It is recommended that the PIF is organised into 4 parts as follows:

Part I : Administrative Documents and Product Summary Part II : Quality Data of Raw Material

Part III : Quality Data of Finished Product Part IV : Safety and Efficacy Data

A Table of Contents should be provided for each of the 4 parts.

Part I: Administrative Documents and Product Summary

The first part of the PIF contains the administrative documents and key summary information that is specific to a single product i.e. this part will provide an ample overview of the finished product.

1. Administrative documentation

   • Copy of the Notification Note; this will include the identity of the product, the name and address of the manufacturer, assembler, importer and CNH

   • Letter of Authorisation by product owner or Letter of Declaration and Letter of Contract Manufacturing, if applicable

   • Any other relevant administrative documents that may be prescribed by the local authorities e.g. License to Operate, Certificate of Incorporation of the Company

1. Qualitative and Quantitative formula of the product (International Nomenclature for Cosmetic Ingredients (INCI) or other approved reference names and corresponding concentrations of the ingredients):

   • For fragrance materials, name and code number of the composition and the identity of the supplier

1. Product presentation and label, including:

   • Outer and inner labels

   • Consumer information leaflets and instruction for use if part of the product as sold to the consumer

1. Manufacturing Statement:

   • A document issued/endorsed by recognised body indicating that the product was manufactured according to the Guidelines for Cosmetic GMP or any it’s equivalent

   • Provide the batch coding system/ key of the product

1. Safety Assessment (summary) as per the Guidelines for the Safety Assessment of a Cosmetic Product:

   • Safety statement (signed statement of opinion, including the name and qualifications of the safety assessor)

1. Confirmed undesirable effects on human health (summary)

1. On-pack product claim support (summary):

   • Summary report of the Efficacy Assessment of the product, based on its composition or on tests performed

Part II: Quality Data of Raw Materials

The second part of the PIF should include full technical information on the quality of the raw materials/ ingredients:

1. Specifications and test methods of raw material/ ingredients:

   • Specifications of each ingredient including water specification, if appropriate

   • Method of analysis corresponding to the specifications for each ingredient, including identification of the ingredients

   • For fragrance materials, specify the name and code number of the fragrance, name and address of the supplier, declaration of compliance with the acceptable or recognised standard for fragrance

1. Data on the safety of the raw materials based on data from the supplier, on published data or on reports from Scientific Committees like the ASEAN Cosmetic Scientific Body (ACSB), the EU Scientific Committee on Consumer Products (SCCP) or the US Cosmetic Ingredient Review Board (CIR).

Part III: Quality Data of Finished Product

The third part of the PIF supplies the detailed technical information on the quality of the finished product:

1. Qualitative and quantitative formula of the product (INCI or other approved reference names and corresponding concentrations of the ingredients):

   • The formula should specify the functions of each raw material/ ingredient

1. Manufacturing:

   • Manufacturer contact details: name, country and address of manufacturer, assembler and packager

   • Summary of the Manufacturing Process

   • Additional detailed information on the manufacturing process, quality controls and related manufacturing documents should be made available upon request by the NPRA

1. Specifications and test methods of the finished product:

   • The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products

   • Method of Analysis corresponding to the specifications for checking compliance

1. Product Stability Summary Report:

   • The stability testing data and report or stability assessment to support the expiry date

Part IV: Safety and Efficacy Data

The fourth and final part of the PIF provides detailed information on the safety assessment and data of the finished product and also relevant efficacy data to support any claims made on the product.

1. Safety Assessment:

   • Signed assessment report of the safety for human health of the finished product based on its ingredients, their chemical structure and level of exposure

   • Curriculum Vitae of the safety assessor

1. The latest compiled report on confirmed or recorded adverse events or undesirable effects on human health resulting from use of the cosmetic product:

   • The adverse event report in the PIF is expected to be updated by the company on a regular basis

1. On-pack product claim support:

   • Full signed report of the efficacy assessment of the product, based on its composition or on tests performed

   • Supporting data including literature review for claimed benefits of cosmetic products should be made available to justify the nature of its effect

2.Who is responsible to keep the PIF

The CNH shall keep the PIF readily accessible to the regulatory authority at the address specified on the label.

It is recommended that the PIF is kept for a minimum period of 3 years after the product is last placed in the market.

3.PIF Audits

1. Types of audits:

Since the PIF must be at the address specified on the label, the NPRA can audit the PIF at that address. There are 2 possibilities:

• Routine audits: The NPRA will announce these audits in advance. It is recommended that the audit be announced sufficiently in advance (e.g. at least 1 month) for the company to prepare for the audit;

• Ad-hoc audits: These may be triggered by results found on samples from the market, by consumer complaints, etc. It is recommended that the audit be announced at least 48 hours in advance. In case of extreme urgency the auditing can take place without announcement;

3.2Documents to be made readily available:

While the whole PIF should be available, in order to facilitate the preparation of the industry, in particular the SMEs as well as the importers/ distributors, the documents in Part I of the PIF should be made readily available especially for initial investigative audits.

3.3Documents to be made accessible to NPRA within reasonable time:

Upon specific request from the NPRA, documents, detailed information or reports in other parts of the PIF should be available and made accessible to the NPRA within an agreed upon time frame: within 15 to 60 calendar days or shorter, depending on the urgency of the audit.

3.4Proprietary Information:

Noting that due to trade secrets, the product owner may not disclose some of the product information in any part of the PIF, the CNH will need to make their own arrangements with the product owner to provide the relevant and necessary information directly to the NPRA upon request.

3.5Background or supplementary documents:

In general the information provided in the PIF should be sufficient for review to ensure “the safety, quality and claimed benefits of all cosmetic products in the market”.

However, in some specific cases, other background or supplementary information supporting the PIF documents (e.g. product experience, microbiological challenge tests, additional confirmatory test methods, production records, etc.) may be necessary. The CNH should then make all efforts to provide the requested information to the NPRA.

3.6Document media:

There are no specific requirements on what media type the PIF documents should be presented. Hence the company may choose any suitable media i.e. paper, electronic, etc. provided they are convenient and could be easily consulted by the NPRA.

All cosmetic products must be notified with the NPRA before it can be marketed in Malaysia . A foreign company wishing to bring cosmetic products into Malaysia would first have to appoint a local agent (a company registered in Malaysia ) to be the holder. The appointed agent would then be responsible for all matters pertaining to the notification of the products.