harmonization of technical requirements; 12... · harmonization of technical requirements; ... iso...

Harmonization of technical requirements;

AHCRS (ASEAN Cosmetic Regulatory Scheme) was signed by the Government of the 10 Member Countries in September 2003;

ASEAN Cosmetic Directive is implemented to eliminate the barriers to trade;

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Safety of products as per article 3: “products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use”;

Quality of products as per article 8.c: “method of manufacture complying with the good manufacturing practice as laid down in the ASEAN Guidelines for Cosmetic Good Manufacturing Practice appearing as Appendix VI”;

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Efficacy of products as per article 8.f: “supporting data for claimed benefits of cosmetic products should be made available; to justify the nature of its effect”;

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Safety assessment is mandatory, a copy of the report must be in the PIF: ◦ Summary in Part 1;

◦ Full report in Part 4;

Health related consumer complaints must be in the PIF: ◦ Summary in Part 1;

◦ Full report in Part 4:

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GMP/GDP is a mandatory requirement!

Compliance to ASEAN GMP Guidelines (or ISO 22716:2007) is mandatory, certification by an accredited body is not mandatory;

Attestation of compliance from the manufacturing site must be in the PIF part 1;

GMP/GDP compliance is part of the product safety;

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The following GMP guidelines/requirements are equivalent to the

ASEAN Cosmetic GMP Guideline:

1. WHO GMP for Pharmaceuticals

2. PIC/S/ GMP for Pharmaceuticals

3. ISO 22716: 2007

Any amendments to the above guidelines will be subjected to discussion and

agreement by the ACC

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Article 8 lists all the requirements of the PIF;

The PIF Guidelines explains how to organize the PIF and how and when the Authorities can and will audit;

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Appendix II of the ACD details the labeling requirements;

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Must be on outer packaging or, when there is no outer packaging, on the immediate packaging:

Name and function of product;

Instructions on the use;

Full ingredient listing using INCI, USP, BP or CAS names;

Country of Manufacture;

Name & Address of company or person responsible for putting product on the local market;

Contents by weight or volume in metric;

Manufacturer’s batch number;

Manufacturing or expiry date (mandatory if durability <30 months);

Special precautions (as stated in annexes III, IV, VI, VII);

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If size, shape or nature of container does not allow for all info to be displayed, use of leaflets, pamphlets, hang tags, display panel, shrink wrap, etc shall be allowed. Name of product and batch number must be on immediate packaging;

All info shall be legible, comprehensible and indelible;

English and/or National Language shall be used;

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Appendix III of the ACD details the Claims Guidelines;

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Only cosmetic claimed benefits;

No medicinal or therapeutic;

Justified by technical data and/or cosmetic formulation or preparation;

Text name, trademarks, pictures, figurative or other signs shall not be misleading;

Watch for the web site!

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Annexes II to VII control some ingredients that are either banned, restricted or must be used for a specific purpose;

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List of Substances which must not form part of the composition of Cosmetic Products i.e. substances which are banned in cosmetic products (Negative List);

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Substance CAS Number Ref. No

Aminophylline 317-34-0 A1136

Theophylline 58-55-9 A1137

Methylene chloride (Dichloromethane) 75-09-2 A1138

Chlorofluorocarbons A1139

Diethylene glycol 111-46-6 A1140

Azelaic acid 123-99-9 A1141

Bimatoprost 155206-00-1 A1142

N-5-Chlorobenzoxazol-2-yl acetamide 8024-12-2 1

-Acetoxyethyl trimethylammonium hydroxide (acetylcholine and its salts) 60-31-1 2

Deanol aceglumate 3342-61-8 3

Spironolactone 52-01-7 4

[4-(4-Hydroxy-3-iodophenoxy)-3,5-diodophenyl] acetic acid and its salts 5

Methotrexate 59-05-2 6

Aminocaproic acid and its salts 60-32-2 7

Cinchophen, its salts, derivatives and salts of these derivatives 132-60-5 8

Thyropropic acid and its salts 51-26-3 9

Trichloroacetic acid 76-03-9 10

Aconitum napellus L. (leaves, roots and galenical preparations) 11

Aconitine (principal alkaloid of Aconitum napellus L.) and its salts 302-27-2 12

Adonis vernalis L. and its preparations 13

Epinephrine 51-43-4 14 16

List of substances which cosmetic products must not contain except subject to restriction and conditions laid down i.e. list of restricted substances;

For each substance there is a field of application and/or use; a maximum authorized concentration in the finished product, other limitations as well as conditions of use and warning which must be printed on the label;

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Ref #

Substance Restrictions Conditions of use and

warning which must be

printed on the labels Field of application

and/or use Maximum authorised

concentration in the

finished cosmetic

product

Other limitations and

requirements

a B C d e f

2b Thioglycolic acid esters Hair waving or

straightening

products:

- General use

- Professional use

- 8% ready for use pH 6-9.5

- 11% ready for use

pH 6-9.5

Percentages

calculated as thioglycollic acid.

The directions for use

drawn up in the national

or official language(s)

must obligatorily

incorporate the following sentences:

May cause

sensitisation in the

event of skin contact.

Avoid contact with eyes.

In the event of

contact with eyes,

rinse off with

plenty of water

and seek medical advice.

Wear suitable gloves.

- Contains thioglycollate.

- Follow the instructions.

- Keep out of reach of children.

- For professional use only.

3 Oxalic acid, its esters and

alkaline salts Hair care products 5% - For professional use

only

4 Ammonia 6% calculated as NH3 - Above 2%: contains ammonia

5 Tosylchloramide sodium 0.2%

6 Chlorates of alkali metals (a) Toothpaste

(b) Other uses

(a) 5%

(b) 3% 18

List of coloring agents allowed for use (positive list). Each color is described by its color index and fields of allowed application are listed:

1. All cosmetic products;

2. All products except those to be applied in the vicinity of the eyes;

3. Allowed exclusively in products to come in contact with the mucous membrane;

4. Allowed exclusively in products intended to come in contact briefly with the skin;

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Colour Index Number or Denomination

Colour Field of application Other limitations and requirements

1 2 3 4

10006 Green X

10020 Green X

10316 (2) Yellow X

11680 Yellow X

11710 Yellow X

11725 X

11920 X

12010 Red X

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List of Preservatives which cosmetic products may contain (positive list);

Each substance is described with its maximum authorized concentration, limitations/requirements and conditions for use/warnings;

Substances with a (+) can be used at a different concentration if they are used for a different

purpose than to preserve the product

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5 Formaldehyde and paraformaldehyde

0.2% ( except for products for oral hygiene)

0.1% ( products for oral hygiene)

expressed as free formaldehyde

Prohibited in aerosol dispensers (sprays)

7 Biphenyl-2-ol (o-phenylphenol) and its salts

0.2% expressed as phenol

8 Zinc pyrithione (+)(3) (CAS No 13463-41-7)

Hair products; 1.0 %

Other products; 0.5%

Rinse off products only.

Not for use in products for oral care

9 Inorganic sulphites and hydrogensulphites (+)(4)

0.2% expressed as free SO2

Reference Number

Substance Maximum authorized concentration

Limitations and requirements Conditions of use and warnings which must be

printed on the label a b c d e

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List of UV Filters which cosmetic products may contain (positive list);

Each substance is described with its maximum concentration, other limitations and conditions of use/warnings;

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Reference number

Substance Maximum Authorised

concentration Other limitations and

requirements Conditions of use and

warnings which must be printed on the label

a b c D e

A28 Menthyl anthranilate 5 % Do not stay too long in

the sun, even while

using a sunscreen product

A29 Zinc oxide 25 % in sunscreen products

Do not stay too long in

the sun, even while


1 Deleted

2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidene methyl) anilinium methyl sulphate

6% Do not stay too long in

the sun, even while


3 Homosalate () 10% Do not stay too long in

the sun, even while


4 Oxybenzone () 10% Contains oxybenzone1

Do not stay too long in

the sun, even while


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ACC: ASEAN Cosmetic Committee tasked with coordination, review and monitoring of the implementation of the Directive. Composed by representatives of each Member State, ASEAN Secretariat and ASEAN Cosmetic Association (ACA);

ACSB: ASEAN Cosmetic Scientific Body tasked with making recommendations to ACC on safety, technical and scientific matters (e.g. modification of annexes II to VII, borderline products);

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The company or person responsible for placing the cosmetic products in the market shall: ◦ ensure that the product will not cause damage to human

health when applied under normal or reasonably foreseeable conditions of use (safety assessment);

◦ notify the regulatory authority before the product is placed on the market;

◦ keep the product’s technical and safety information readily accessible to the regulatory authority (PIF: Product Information File, article 8);

Companies must have adequate knowledge/experience of the

requirements of the Directive

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Be aware of the law: ◦ Up to 8,000 US$ or 6 months jail or both for an

individual who fails to comply with the requirement;

◦ Up to 16,000 US$ or 12 months jail or both for providing false or misleading record;

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All countries except Thailand have transposed the ACD into local regulations;

All countries are implementing the principles of ACD: ◦ Product notification;

◦ PIF requirement;

◦ Annexes to control ingredients;

◦ GMP – GDP requirements;

◦ Post market surveillance;

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Indonesia: ◦ Notification with quantitative formula;

◦ Mandatory expiry date;

◦ Name of licensor if product made under license;

◦ Name of primary manufacturer is product final pack is made by a different company;

◦ Certificate of Free Sale;

◦ Letter of representation legalized;

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Thailand: ◦ Has not transposed the ACD into local

regulation;

◦ Notification number to be printed;

◦ Product picture and artwork need to be uploaded;

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Vietnam: ◦ Certificate of Free Sale;

◦ Letter of representation legalized;

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Brunei Darussalam;

Cambodia;

Laos;

Malaysia;

Philippines;

Singapore

are keeping to the ACD and the ACC agreements

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The Company or Person placing a cosmetic product in the market shall: ◦ Notify the regulatory authorities before the

product is put in the market (article 1-3)

◦ Ensure that they will not cause damage to human health under normal or reasonably foreseeable conditions of use (article 3)

◦ Keep the product information file readily accessible to the regulatory authorities (article 8)

◦ Must have adequate knowledge or experience (article 8-d)

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Must be at the address of the Company responsible for placing the product in the market (as specified on the label): manufacturer, importer or distributor;

PIF must be in the local language or English;

Must be “readily accessible”;

Must be kept updated of all modifications;

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1. Qualitative and quantitative composition of the product: name and percentage of ingredients (for perfumes: name of supplier, code of perfume and percentage);

2. Specifications of the raw materials and finished product (physico-chemical and microbiological);

3. Manufacturing method complying with ASEAN GMP Guidelines;

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

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5. Existing data on undesirable effects on human health resulting form the use of the product;

6. Supporting data for claimed benefits (efficacy assessment);

7. Available methods used to check the ingredients corresponding with the certificate of analysis (Article 9, i.e. upon request);

8. Criteria used for microbiological control; chemical purity of ingredients and/or methods for checking compliance with those criteria;

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Article 8 states clearly that the PIF must be at the address of the company placing the product in the market: ◦ This is the address printed on the label whether

importer, manufacturer or distributor;

◦ Recommendation is to keep the PIF for 3 years minimum after the last product is put in the market;

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Routine audits: ◦ Recommendation is for the Authorities to announce

these audits at least 1 month in advance for the company to prepare;

Ad-hoc audits: ◦ Triggered by results found on samples from the

market, by consumer complaints, etc;

◦ Recommendation is to announce 48h in advance, except if urgent;

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Part I should be available immediately;

Upon specific request, any other document should be made available to the Authorities within an agreed timeframe i.e. 15 to 60 calendar days (can be shorter depending on the urgency);

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Proprietary information: ◦ Noting that due to trade secrets, the product owner

may not disclose some of the product information in any part of the PIF, to the distributor/importer, the person or company placing the product in the market will need to make their own arrangements with the product owner to provide the relevant and necessary information directly to the Authorities upon request;

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In some cases background documents or supplementary information may be necessary, the company responsible should make all efforts to provide the information to the Authorities;

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There is no requirement as to the media: paper, electronic, etc, provided the documents can be easily consulted;

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Mercury: 1ppm

Lead: 20ppm

Arsenic: 5ppm

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ASEAN Microbiological Test Limits

Products for children under 3

years, eye area and

mucous membranes Other products

Total Microbial Count

(Bacteria, Yeast & Molds) ≤ 500 cfu/g ≤ 1000 cfu/g

P. aeruginosa

Absence per 0.1g or 0.1ml test

sample

Absence per 0.1g or 0.1ml

test sample

S. aureus


sample


test sample

C. albicans


sample


test sample

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Sunscreen means a preparation intended to be placed on the skin with a view exclusively or mainly to protecting it from UV radiation;

Sunscreen should protect against both UVB & UVA;

No claim should be made that implies: ◦ 100% protection e.g. sunblock, sunblocker, total

protection; ◦ No need to reapply the product e.g. whole day

protection;

Mandatory warning: ◦ Do not stay too long in the sun while using a

sunscreen product;

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Claims should be simple and unambiguous;

Claims of UV protection should not be made if SPF<6;

Low SPF 6 –10

Medium SPF 15-20- 25

High SPF 30–50

Very High (or for extreme

conditions)

SPF 50+

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The Industry association is a partner to the Regulatory Authorities;

Indonesia: PERKOSMI;

Malaysia: FMM-CTIG;

Philippines: CCIP;

Singapore: CTFAS;

Thailand: TCMA;

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ACA the ASEAN Cosmetic Association is the partner;

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ACA has a delegation participating in the ACC and the ACSB;

ACA is a partner to: ◦ China CAFFCI;

◦ Japan JCIA;

◦ Korea KCA

◦ Europe: Cosmetics Europe;

◦ US: PCPC;

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