l1: draft international dihias 08 - 00600 date reference...
TRANSCRIPT
L1: DRAFT INTERNATIONAL HALAL INTEGRITY ALLIANCE STANDARD
WARNING: This document is a Draft International Halal Integrity Alliance Standard (IHI
Alliance). It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Halal Integrity Alliance Standard.
IHI/TC 8 WG8-1,WG8-2,WG8-3 Circulated to TC members and to
organisations in liaison for:
Title Information
HALAL COSMETICS AND PERSONAL CARE Discussion at [venue/date of meeting]
Secretariat Comments by
[date]
Approval for registration as DIHIAS in accordance with TC directives, by
[date]
HALAL COSMETICS AND PERSONAL CARE
Copyright Notice
This document is a committee draft and its copyright is protected by IHI Alliance. While the reproduction of this document in any form for use of participants in the IHI Alliance Halal standard development process is permitted without prior written permission from IHI Alliance, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from IHI Alliance. © IHI Alliance 2010 - All rights reserved
DIHIAS 08 - 00600 Date Reference number
21-06-2010 IHIAS/TC8 N1.5 Supercedes document
N1.4
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CONTENTS
Foreword .................................................................................................................... 5 Introduction ………..................................................................................................... 6 1.0 Scope.............................................................................................................................. 7 2.0 Normative references..................................................................................................... 7 3.0 Definitions...................................................................................................................... 7 3.1 Shariah........................................................................................................................... 8 3.2 Halal............................................................................................................................... 8 3.3 Non-Halal / Haram ....................................................................................................... 8 3.4 Shubhah ........................................................................................................................ 9 3.5 3.6 3.7
Najs ............................................................................................................................. The Organisation ............................................................................................................ Ritual Cleansing ..............................................................................................................
9
9
10 3.8 Batch ............................................................................................................................. 10 3.9 Bulk Product................................................................................................................... 10 3.10 Calibration ..................................................................................................................... 10 3.11 Cosmetics and personal care ......................................................................................... 10 3.12 Halal cosmetics and personal care .................................................................................. 10 3.13 Documentation ............................................................................................................. 11 3.14 Product ......................................................................................................................... 11 3.15 Raw materials ............................................................................................................... 11 3.16 Processing aids ............................................................................................................. 11 4.0 Requirements ................................................................................................................ 11 4.1 Organisation, Qualification and Responsibilities ............................................................. 12 4.2 Training .......................................................................................................................... 14 4.3 Premises......................................................................................................................... 14 4.4 Equipment …….…............................................................................................................ 16
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5.0 Cosmetics and personal care production........................................................................ 19 5.1 Raw Materials ................................................................................................................ 19 5.2 Starting materials .......................................................................................................... 20 5.3 Verification Materials .................................................................................................... 20 5.4 Rejected Materials ......................................................................................................... 21 5.5 Batch Numbering System ............................................................................................... 21 5.6 Weighing and Measurement .......................................................................................... 21 5.7 Procedure and Processing .............................................................................................. 21 5.8 Dry Products .................................................................................................................. 22 5.9 Wet Products ................................................................................................................. 22 5.10 Labelling and Packaging ................................................................................................. 23 5.11 Finished Product: Quarantine and Delivery to Finished Stock ……………………………………… 24 6.0 Quality Control................................................................................................................ 24 6.1 Quality control system.................................................................................................... 24 6.2 Reprocessing .................................................................................................................. 24 6.3 Returned Products ......................................................................................................... 24 7.0 Documentation ……………................................................................................................. 25 7.1 Document system .......................................................................................................... 25 7.2 Specifications ................................................................................................................. 25 7.3 Documents for Production ............................................................................................. 26 8.0 Internal Audits ……......................................................................................................... 27 9.0 Storage .......................................................................................................................... 28 9.1 Storage areas ................................................................................................................. 28 9.2 Stock Handling and Control ............................................................................................ 28 10.0 Contract Manufacturing and Analysis ............................................................................. 29 11.0 Complaints ..................................................................................................................... 29 12.0 Product Recalls .............................................................................................................. 30 13.0 Legal Requirements ....................................................................................................... 31
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14. Marking ......................................................................................................................... 31 15. Halal Cosmetics and Personal Care Certification ............................................................. 32 15.1 Organisation …............................................................................................................... 32 15.2 Compliance .................................................................................................................... 32 15.3 Certification mark .......................................................................................................... 32
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© IHI Alliance 2010 – All rights reserved TC 8 Halal Cosmetics & Personal Care
FOREWORD
International Halal Integrity Alliance (IHI Alliance) is a non-government, non-profit
organisation, set up following a resolution passed by international delegates from over 30
countries, consisting of cross section of stakeholders across the whole industry supply chain,
at the World Halal Forum 2006. IHI Alliance was mandated to spearhead the development
of the International Halal Standard. This mandate was reinforced by a resolution passed at
the Organisation of Islamic Conference (OIC) in March 2008 through our partnership with
the Islamic Chamber of Commerce and Industry (ICCI) to be the one voice representing
values regards to Halal and quality control.
The IHI Alliance Standards are developed in accordance to guidelines adapted from ISO/IEC
(the International Organization for Standardization / the International Electrotechnical
Commission), Guidelines for International Standards Development, while adhering to WTO-
TBT (World Trade Organization-Technical Barriers to Trade) Code of Good Practice for
Standards Development.
The work of preparing International Halal standards is carried out through IHI Alliance
technical committees. Each member body interested in a subject that a technical committee
has been established has the right to be represented on that committee, international
organisation, governmental and non-governmental, industry players, and Shariah experts, in
liaison with IHI Alliance, also take part in the development.
The main task of technical committees is to prepare international Halal standards. Draft IHI
Alliance Standards prepared by technical committees will be circulated among stakeholders
for comment. Publication as a final International Halal Standards requires approval by IHI
Alliance Shariah Board and Standards Management Board.
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INTRODUCTION 1 2 Cosmetics are substances used to enhance or protect the appearance of the human body. It 3 is extremely important that Halal cosmetics and personal care manufacturing is segregated 4 from non Halal products, to avoid cross contamination and mistakes and to ensure that the 5 production is consistent with the expectations of the stakeholders. 6 7 The concept of Halal cosmetics and personal care processing is incomplete without coupling 8 it with best practice in cosmetics production, that is, traceability is in place, ensures an 9 unbroken cold chain, protection of shelf life by short supply chain lead times and high 10 hygiene and sanitation standard. 11 12 This document is a comprehensive standard for Halal Cosmetics and Personal Care 13 processing worldwide, incorporating the good manufacturing practice (GMP), Islamic 14 schools of thought (Madzhab) and local Halal standards. 15
16
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1 SCOPE 17
18
This standard prescribes practical guidelines for the Halal cosmetic and personal care 19
industry. It serves as a basic requirement for cosmetic and personal care industry in 20
managing product formulation, procurement, receiving, production, storage and distribution 21
through the organisation and the supply chain in compliance with the general principles of 22
Shariah. 23
24
This standard is applicable to activities encompassing places, institutions and companies 25
responsible for cosmetic and personal care production. 26
27
It is not applicable to materials handling covered under IHIAS 0100:2010 (Logistics) and 28
DIHIAS 0300 (Laboratory Testing and Analysis – to be published in 2011). 29
30
31
2 NORMATIVE REFERENCES 32
33
The following referenced documents are indispensable for the application of this standard. 34
MS 2200: Part 1:2008, Islamic consumer goods - Part 1: Cosmetic and personal care - 35
General guidelines. 36
MS 1900:2005, Quality Management Systems – Requirements from Islamic Perspectives. 37
ASEAN Guidelines for Cosmetic Good Manufacturing Practice, Appendix VI 38
National Pharmaceutical Control Bureau, Malaysia, Guidelines on Cosmetic Good 39
Manufacturing Practice. 40
ISO 9001 (R):2008, Quality Management Systems – Requirements 41
IHIAS 0100:2010, ICCI-IHI Alliance Halal Standard – Logistics (First Edition) 42
DIHIAS 0300, ICCI-IHI Alliance Draft Halal Standard – laboratory Testing and Analysis 43
(First Edition to be published in 2011) 44
45
46
47
3 Definitions 48
49
For the purposes of this standard, the following definitions apply. 50
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51
3.1 Shariah 52
Islamic Law that covers both matters of belief (aqidah) and Jurisprudence – the theory or 53
philophy of law (fiqh). 54
55
NOTE The sources of Islam are the Sacred Book (Quran), the sayings of the Prophet Mohammad peace be upon 56
him (Sunnah), consensus (ijma) and anology (Qiyas). 57
58
Islam is perceived as comprising 3 basic elements; 59
60
i. AQIDAH : concerns all forms of faith and belief by Muslim in Allah the Almighty God 61
and His Will 62
63
ii. AKHLAK : concerns behaviour, attitude and work ethics with which a Muslim 64
performs his practical action. 65
66
iii. SHARIAH : concerns all forms of practical actions by a Muslim manifesting his faith 67
and belief. 68
69
Shariah is defined as the practical aspects of a Muslim’s daily life which comprises of 2 parts, 70
71
i) IBADAT : concerns the practicalities of worship to Allah (man-to-Allah relationship) 72
73
ii) MUAMALAT : concerns the practicalities of various daily life routines (man-to-man 74
relationship) 75
76
3.2 Halal 77
78
Things or actions, that is permissible or lawful under Shariah. 79
80
3.3 Non-Halal/Haram 81
82
Things or actions that are not classified as Halal according to this standard, and things or 83
actions that are forbidden or unlawful under Shariah. 84
85
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3.4 Shubhah 86
87
Things or actions that are doubtful, and its status is not definitely known whether it is Halal 88
of Haram (e.g the nature of raw material used in production). 89
90
3.5 Najs 91
92
3.5.1 Najs according to Shariah are: 93
94
a) things that are themselves not permissible such as pig and all its derivatives, blood and 95
carrion; 96
b) any liquid and objects discharged from the orifices of human beings or animals such as 97
urine, excrement, blood, vomit, pus, sperm and ova of pigs and dogs except sperm and 98
ova of other animals; 99
c) carrion or Halal animals that are not slaughtered according to Shariah 100
d) Halal products that come into direct contact (contaminated) with things that are najs by 101
Shariah 102
103
NOTE Adapted from MS 2200:Part 1:2008 104
105
3.5.2 There are two types of najs relevant to the cosmetics and personal care industry. 106
107
3.5.2.1 Severe najs which is considered as Mughallazah, namely pig and dog and its liquid, 108
objects discharged from their orifices, descendants and derivatives. 109
110
3.5.2.2 Medium najs, which is considered as Mutawassitah, namely alcoholic beverages 111
(khamar), carrion, or Halal animals that are not slaughtered according to the Shariah, blood, 112
vomit, pus, liquid and objects discharged from the orifices, etc. 113
114
3.6 The organisation 115
116
Any commercial cosmetic or personal care manufacturing establishment that produces 117
cosmetic or personal care products. 118
119
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3.7 Ritual cleansing 120
121
Process specified to follow by Shariah to remove severe najs materials. In some cases the 122
process must ensure complete elimination of residues, smell and/or colour. 123
124
NOTE Ritual cleansing practices may differ under the four (4) Schools of Thought when there is contamination 125
by severe najs. 126
127
3.8 Batch 128
A quantity of any cosmetic product produced in a given cycle of manufacture that is uniform 129
in character and quality. 130
131
3.9 Bulk Product 132
A processed product that will have to undergo the packaging operation in order to become a 133
finished product. 134
135
3.10 Calibration 136
Combination of checking an instrument and adjusting it to bring it within its limits for 137
accuracy according to recognised standards. 138
139
3.11 Cosmetics and personal care 140
Any substance or mixture of substances, manufactured, sold or represented for use in 141
cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants 142
and perfumes. The products are not being presented as treating or preventing disease in 143
human beings. 144
145
This definition includes (but is not limited to) soap, grooming products for animals, and 146
cosmetics used by professional aesthetic services (e.g. facial masks, manicure preparations, 147
hair dye).This also encompasses bulk products used by institutional services (e.g. handsoap 148
in school restrooms). 149
150
3.12 Halal cosmetics and personal care 151
152
Halal cosmetics and personal care products, including accessories are products permitted 153
under Shariah and fulfil the following conditions: 154
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a) Do not comprise or contain any human parts or ingredients derived from thereof; 155
b) Do not comprise of or contain any parts or substance derived from animals forbidden to 156
Muslims by Shariah, to use or to consume or from halal animal which are not 157
slaughtered according to Shariah; 158
c) Do not contain any materials or genetically modified organisms (GMO) which are 159
decreed as najs according to Shariah; 160
d) Are not prepared, processed, manufactured or stored using any equipment that is 161
contaminated with things that are najs according to Shariah; 162
e) During its preparation, processing or manufacturing, the product is not in contact and is 163
physically segregated from any materials that do not meet the requirements stated in 164
items a), b), c) or d); and 165
f) Do not harm the consumer or the user. 166
NOTE Adopted from MS2200:Part 1:2008 167
168
3.13 Documentation 169
All written procedures, instructions and records involved in the manufacture and quality 170
control of products. 171
172
3.14 Product 173
Any substance or preparation intended to be used, or capable or purported or claimed to be 174
capable of being used, in or for cleansing, improving, altering or beautifying the complexion, 175
skin, hair or teeth. 176
177
3.15 Raw Materials 178
Any ingredient to be used in the formulation and manufacturing of a cosmetic product. 179
180
3.16 Processing aids 181
182
A substance that is added to a product for its technical or functional effect in the processing 183
stage but is present in the finished product at insignificant levels and does not have any 184
technical or functional effect in that product. 185
186
187
4 REQUIREMENTS 188
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189
4.1 Organisation, Qualification and Responsibilities 190
191
4.1.1 The organisation shall ensure they employ the adequate number of personnel 192
having knowledge, experience, skill and capabilities relevant to their assigned function. They 193
should be in good health and capable of handling the duties assigned to them. 194
195
4.1.2 The organisational structure of the company shall be such that the production and 196
the quality sections are headed by different persons, neither of whom shall be responsible 197
to the other. 198
199
4.1.3 The organisation shall ensure that the head of production is adequately trained and 200
experienced in cosmetic manufacturing. He should have authority and responsibilities to 201
manage production of products covering operations, equipment, production personnel, 202
production areas and records. 203
204
4.1.4 The organisation shall ensure that the head of quality should be adequately trained 205
and experienced in the field of quality system duties such as establishment, verification and 206
implementation of all quality system procedures. He should have the authority to 207
designate/assign, when appropriate, personnel to approve starting materials, intermediates, 208
bulk and finished products that meet the specification or to reject those which do not 209
conform to the relevant specification or which were not manufactured in accordance with 210
approved procedures and under the defined conditions. 211
212
4.1.5 The organisation shall ensure that the responsibilities and authority of key personnel 213
are clearly defined. 214
215
4.1.6 The organisation shall ensure that there is an adequate number of trained personnel 216
appointed to execute direct supervision in each section of the production and quality control 217
unit. 218
219
220
221
222
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223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
Figure 4.1: Generic cosmetics and personal care process flow 250
251
NOTE 1 The process flow above may differ depending on the type of products the organisation manufactures 252
NOTE 2 * Indicates Halal Critical Control Point (HCCP) 253
254
4.1.7 The organisation should follow the Halal Critical Control Point for cosmetics and 255
personal care listed below: 256
HCCP 1 Product formulation 257
*RAW MATERIALS AND
PACKAGING STORAGE
DOCUMENTATION AUDIT
*SUPPLIER OF
RAW MATERIALS
LABORATORY
EQUIPMENT
CALLIBRATION
c
*LOGISTICS
WASTE WATER
TREATMENT WAREHOUSING
SUPPLIER OF PACKAGING
MATERIALS
PRIMARY SUPPLY CHAIN PROCESS
MANUFACTURING
PROCESSING
- MAKING
- FILLING
- HANDLING
SECONDARY SUPPLY CHAIN
PROCESS
*PRODUCT
FORMULATION
RAW MATERIAL LABORATORY
TESTING (OPTIONAL)
FINISHED PRODUCT
STORAGE
RETAILER /
CONSUMER
HCCP 1
HCCP 2
HCCP 3
HCCP 4
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HCCP 2 Supplier of raw materials 258
HCCP 3 Raw materials and packaging storage 259
HCCP 4 Logistics 260
261
NOTE For logistics, refer to IHIAS 0100:2010, ICCI-IHI Alliance Halal Standard, Logistics 262
263
4.2 Training 264
265
4.2.1 The organisation shall ensure that all personnel directly involved in the 266
manufacturing activities is appropriately trained in manufacturing operations in accordance 267
to good manufacturing practice (GMP) principles. Special attention should be given to 268
training of personnel working with any hazardous materials. 269
270
4.2.2 The organisation should ensure that training in GMP is conducted on a continuous 271
basis. 272
273
4.2.3 The organisation shall ensure that records of training are maintained and its 274
effectiveness assessed periodically. 275
276
4.3 Premises 277
278
4.3.1 The organisation shall ensure that the premises for manufacturing are suitably 279
located, designed, constructed and maintained. 280
281
4.3.2 The organisation shall ensure that effective measures are taken to avoid any 282
contamination from the surrounding environment and from pests. 283
284
4.3.3 Household products containing non-hazardous materials/ingredients and cosmetic 285
products can share the same premises and equipment. . The organisation shall ensure that 286
due care is exercised to prevent cross contamination and risk of mix-up. Painted lines, plastic 287
curtains and flexible barriers in the form of rope or tape may be employed to prevent mix-288
up. 289
290
4.3.4 The organisation shall ensure that appropriate changing rooms and facilities are 291
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provided. Toilets should be separated from the production areas to prevent product 292
contamination/cross contamination. 293
294
4.3.5 The organisation should ensure that these defined areas are provided for, wherever 295
possible and applicable: 296
a) Materials receiving 297
b) Materials sampling 298
c) Incoming goods and quarantine 299
d) Starting materials storage 300
e) Weighing and dispensing 301
f) Processing 302
g) Storage of bulk products 303
h) Packaging 304
i) Quarantine storage before final release of products 305
j) Storage of finished products 306
k) Loading and unloading 307
l) Laboratories 308
m) Equipment washing 309
310
4.3.6 The organisation should ensure that walls and ceilings, where applicable, are 311
smooth and easy to maintain. The floor in the processing areas should have a surface that is 312
easy to clean and sanitise. 313
314
4.3.7 The organisation should ensure that drains are of adequate size and should have 315
trapped gullies and proper flow. Open channels should be avoided where possible, but if 316
required they should be able to facilitate cleaning and disinfection. 317
318
4.3.8 The organisation shall ensure that air intakes and exhausts and associated pipework 319
and ducting, when applicable, are installed in such a way as to avoid product contamination. 320
321
4.3.9 The organisation shall ensure that buildings are adequately lit and properly 322
ventilated appropriate to the operations. 323
324
4.3.10 The organisation shall ensure that pipework, light fittings, ventilation points and 325
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other services in manufacturing areas are installed in such a way as to avoid uncleanable 326
recesses and run outside the processing areas. 327
328
4.3.11 The organisation should ensure that laboratories are physically separated from the 329
production areas. 330
331
4.3.12 The organisation shall ensure that storage areas have adequate space with suitable 332
lighting arranged and equipped to allow dry, clean and orderly placement of stored 333
materials and products. 334
335
4.3.13 The organisation should ensure that storage areas are suitable for effective 336
separation of quarantined materials and products. Special and segregated areas should be 337
available for storage of flammable and explosive substances, highly toxic substances, 338
rejected and recalled materials or returned goods. 339
340
4.3.14 The organisation shall ensure that special storage conditions e.g. temperature, 341
humidity and security, where required, are provided. 342
343
4.3.15 The organisation should ensure that storage arrangements permit separation of 344
different labels and other printed materials to avoid mix-up. 345
346
4.4 Equipment 347
348
The organisation shall ensure that equipment are designed and located to suit the 349
production of the product. 350
351
4.4.1 Design and Construction 352
353
4.4.1.1 The organisation shall ensure that the equipment surfaces coming into contact with 354
any in-process material does not react with or adsorb the materials being processed. 355
356
4.4.1.2 The organisation shall ensure that the equipment does not adversely affect the 357
product through leaking valves, lubricant drips and through inappropriate modifications or 358
adaptations. 359
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360
4.4.1.3 The organisation shall ensure that equipments are easily cleaned. 361
362
4.4.1.4 The organisation shall ensure that equipment used for flammable substances are 363
explosion proof. 364
365
4.4.2 Installation and Location 366
367
4.4.2.1 The organisation shall ensure that equipments are located to avoid congestion and 368
are properly identified to assure that products do not become admixed or confused with 369
one another. 370
371
4.4.2.2 The organisation shall ensure that water, steam, and pressure or vacuum lines, 372
where applicable, are installed so as to be easily accessible during all phases of operation. 373
They should be clearly identified. 374
375
4.4.2.3 The organisation shall ensure that support system such as heating, ventilation, air 376
conditioning, water (such as potable, purified, distilled), steam, compressed air and gases 377
(example: nitrogen) function as designed and identifiable. 378
379
4.4.3 Maintenance 380
381
The organisation shall ensure that weighing, measuring, testing and recording equipment 382
are serviced and calibrated regularly and all records are maintained. 383
384
4.4.4 Sanitation and Hygiene 385
386
The organisation shall ensure that sanitation and hygiene are practiced to avoid 387
contamination of the manufacturing of products. It shall cover personnel, premises, 388
equipment/apparatus and production materials and containers. 389
390
4.4.5 Management and staff 391
392
4.4.5.1 The organisation shall ensure that personnel are healthy to perform their assigned 393
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duties. Regular medical examination must be conducted for all production personnel 394
involved with manufacturing processes. 395
396
4.4.5.2 The organisation shall ensure that personnel practice good hygiene practice (GHP). 397
398
4.4.5.3 The organisation shall ensure that any personnel shown at any time to have an 399
apparent illness or open lesions that may adversely affect the quality of products are not 400
allowed to handle raw materials, packaging materials, in-process materials, and finished 401
products. 402
403
4.4.5.4 The organisation shall ensure that personnel are instructed and encouraged to 404
report to their immediate supervisor any conditions (plant, equipment or personnel) that 405
they consider may adversely affect the products. 406
407
4.4.5.5 The organisation shall ensure that direct physical contact with the product is 408
avoided to ensure protection of the product from contamination. Personnel should wear 409
protective and clean attire appropriate to the duties they perform. 410
411
4.4.5.6 The organisation shall ensure that smoking, eating, drinking and chewing, food, 412
drinks and smoking materials and other materials that might contaminate are not permitted 413
in production, laboratory, storage or other areas where they might adversely affect product 414
quality. 415
416
4.4.5.7 The organisation shall ensure that all authorised personnel entering the production 417
areas practice good personal hygiene including proper attire. 418
419
4.4.6 Personnel hygiene, sanitation and pest control 420
421
4.4.6.1 The organisation shall ensure that adequate washing and well-ventilated toilet 422
facilities are provided for personnel and separated from the production area. 423
424
4.4.6.2 The organisation should ensure that suitable locker facilities are provided at 425
appropriate locations for the storage of employees’ clothing and personal belongings. 426
427
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4.4.6.3 The organisation shall ensure that waste material is regularly collected in suitable 428
receptacles for removal to collection points outside the production area. 429
430
4.4.6.4 The organisation shall ensure that rodenticides, insecticides, fumigating agents and 431
sanitising materials does not contaminate equipment, raw materials, packaging materials, 432
in-process materals or finished products. 433
434
4.4.7 Equipment and Apparatus 435
436
4.4.7.1 The organisation shall ensure that equipment and utensils are kept clean. 437
438
4.4.7.2 The organisation should ensure that compressed air and brushes are used with care 439
and avoided if possible, as they increase the risk of product contamination. 440
441
4.4.7.3 The organisation shall ensure that standard operating procedures are followed for 442
cleaning and sanitising of major machines. 443
444
445
5 COSMETICS AND PERSONAL CARE PRODUCTION 446
447
5.1 Raw Materials 448
449
5.1.1 The organisation shall ensure the following for each raw material (including 450
additives and technological additives) utilised to produce ingredients: 451
a) the name and address of the supplier of the raw material; 452
b) information of the production or process from which the raw material is derived; 453
c) a risk assessment for each raw material, identifying potential hazards and the means by 454
which these hazards are controlled by the supplier, the organisation or both parties. 455
456
5.1.2 Sources of halal cosmetics and personal care; 457
a) sources derived from halal animals, land animals’ fur, hair and related material which 458
were harvested while the animals are still alive are halal. 459
b) sources derived from eggs that are from animals which are not najs are halal 460
c) all aquatic animals that are halal for consumption can be sources for cosmetic and 461
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personal care. 462
d) sources derived from plants and microorganisms are halal for use except those that are 463
hazardous and/mixed with materials that are decreed as najs. 464
e) all sources from the soil, water and its by products are halal for use except those that 465
are hazardous and/mixed with materials that are decreed as najs. 466
f) materials that contain alcohol excluding alcoholic drinks (khamr) are permissible. 467
g) materials that are produced synthetically are halal except those that are hazardous 468
and/mixed with materials that are decreed as najs. 469
470
NOTE Adopted from MS2200:Part 1:2008 471
472
5.2 Starting materials 473
474
5.2.1 Water 475
476
5.2.1.1 The organisation shall ensure that water production equipment and water systems 477
supply quality water. Water systems should be sanitised according to well-established 478
procedures. 479
480
5.2.1.2 The organisation shall ensure that the chemical and microbiological quality of water 481
used in production is monitored regularly, according to written procedures and any anomaly 482
should be followed by corrective action. 483
484
5.2.1.3 The organisation shall ensure that the choice of method for water treatment such as 485
deionization, distillation or filtration depends on product requirement. The storage as well 486
as delivery system should be properly maintained. 487
488
5.3 Verification Materials 489
490
5.3.1 The organisation shall ensure that all deliveries of raw materials and packaging 491
materials are checked and verified for their conformity to specifications and be traceable to 492
the product. 493
494
5.3.2 The organisation shall ensure that samples of raw materials are physically checked 495
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for conformity to specifications prior to release for use. The raw materials should be clearly 496
labeled. All goods must be clean and checked for appropriate protective packing to ensure 497
no leakage, perforation or exposure. 498
499
5.4 Rejected Materials 500
501
The organisation shall ensure that deliveries of raw materials that do not comply with 502
specification are segregated and disposed according to standard operating procedures. 503
504
5.5 Batch Numbering System 505
506
5.5.1 The organisation shall ensure that every finished product bear a production 507
identification number which enables the history of the product to be traced. 508
509
5.5.2 The organisation shall ensure that the batch numbering system is specific for the 510
product and a particular batch number shall not be repeated for the same product in order 511
to avoid confusion. 512
513
5.5.3 The organisation shall ensure that the batch number is printed on the immediate 514
and outer container of the product. 515
516
5.6 Weighing and Measurement 517
518
5.6.1 The organisation shall ensure that weighing is carried out in the defined areas using 519
calibrated equipment. 520
521
5.6.2 The organisation shall ensure that all weighing and measurement carried out is 522
recorded and, where applicable, counterchecked. 523
524
5.7 Procedure and Processing 525
526
5.7.1 The organisation shall ensure that all starting materials used are approved according 527
to specifications. 528
529
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5.7.2 The organisation shall ensure that all manufacturing procedures are carried out 530
according to written procedures. 531
532
5.7.3 The organisation shall ensure that all required in-process controls are carried out 533
and recorded. 534
535
5.7.4 The organisation shall ensure that bulk products are properly labeled until approved 536
by Quality control, where applicable. 537
538
5.7.5 The organisation shall ensure that particular attention is paid to problem of cross-539
contamination in all stages of processing. 540
541
5.7.6 The organisation shall ensure that the processes meet the following requirements: 542
a) all processing lines, tools and utensils are dedicated for halal production only; 543
b) the product or its ingredients do not contain any non-halal or najs component; 544
c) the product is prepared, processed or manufactured using equipment and facilities that 545
are free from contamination with najs; 546
d) throughout its process, the product or its ingredients shall be physically separated from 547
anything that is decreed as najs. 548
549
5.8 Dry Products 550
551
The organisation shall ensure that handling of dry materials and products is given special 552
attention. Where possible, dust-containing production system, central vacuum system or 553
other suitable methods should be employed. 554
555
5.9 Wet Products 556
557
5.9.1 The organisation shall ensure that liquids, creams and lotions are produced in such a 558
way as to protect the product from microbial and other contamination. 559
560
5.9.2 The organisation should ensure the use of closed systems of production and 561
transfer. 562
563
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5.9.3 The organisation should ensure that care is taken to ensure that pipe-lines used for 564
delivery of ingredients or bulk products systems are easy to clean. 565
566
5.10 Labelling and Packaging 567
568
5.10.1 The organisation shall ensure that the packaging line is inspected for clearance prior 569
to operation. Equipment should be clean and functional. All materials and products from 570
previous packaging operation should have been removed. 571
572
5.10.2 The organisation shall ensure that samples are taken and checked at random during 573
labeling and packaging operations. 574
575
5.10.3 The organisation shall ensure that each labeling and packaging line should be clearly 576
identified to avoid mix-up. 577
578
5.10.4 The organisation shall ensure that excess labels and packaging materials should be 579
returned to store and recorded. Any rejected packaging materials should be disposed off 580
accordingly. 581
582
5.10.5 The organisation shall ensure that the packaging material does not contain any raw 583
materials that are considered hazardous to human health. 584
585
5.10.6 The organisation shall ensure that the products are packed following the 586
requirements below: 587
a) packaging materials are not prepared, processed or manufactured using equipment or 588
raw materials that are contanimated with or made from things that are najs; 589
b) during its preparation, processing, storage and transportation, it shall be physically 590
separated from any other things that do not meet the requirements stated in a) or any 591
other things that is najs. 592
593
5.10.7 The organisation shall ensure that each container is marked legibly and indelibly and 594
the information on the label shall be consistent with the labelling requirements in the 595
country of export. 596
597
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5.10.8 The organisation shall ensure that labelling does not contravene with the principles 598
of Shariah and does not display indecent elements which are against Shariah. 599
600
5.11 Finished Product: Quarantine and Delivery to Finished Stock 601
602
The organisation shall ensure that all finished products are approved by Quality Control prior 603
to release. 604
605
606
6 QUALITY CONTROL 607
608
6.1 Quality control system 609
610
6.1.1 The organisation shall ensure that quality control system assures that products 611
contain the correct materials of specified quality and quantity and area manufactured under 612
proper conditions according to standard operation procedures. 613
614
6.1.2 The organisation shall ensure that quality control involves sampling, inspecting and 615
testing of starting materials, in process, intermediate, bulk, and finished products. It also 616
includes, where applicable, environmental monitoring programs, review of batch 617
documentation, sample retention program, stability studies and maintaining correct 618
specifications of materials and products. 619
620
6.2 Reprocessing 621
622
6.2.1 The organisation shall ensure that the methods of reprocessing are evaluated to 623
ensure that they do not affect the quality of the product. 624
625
6.2.2 The organisation shall ensure that additional testing of any finished product which 626
has been reprocessed is performed. 627
628
6.3 Returned Products 629
630
6.3.1 The organisation shall ensure that returned products are identified and stored 631
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separately either in an allocated area or segregated by moveable barrier such as rope or 632
tape. 633
634
6.3.2 The organisation shall ensure that all returned products are tested if necessary, in 635
addition to physical evaluation before being released for distribution. 636
637
6.3.3 The organisation shall ensure that returned products which do not comply with the 638
original specification are rejected. 639
640
6.3.4 The organisation shall ensure that rejected products are disposed according to 641
appropriate procedures. 642
643
6.3.5 The organisation shall ensure that records of returned products are maintained. 644
645
7 DOCUMENTATION 646
647
7.1 Document system 648
The organisation shall ensure that the documentation system adheres to the requirements 649
below: 650
a) documentation system should include the complete history of each batch, from starting 651
materials to finished products. The system should record executed activities for 652
maintenance, storage, quality control, primary distribution and other specific matters 653
related to GMP. 654
b) there is a system in place for preventing the use of any superseded document. 655
c) If an error is made or detected on a document, the organisation shall ensure that it is 656
corrected in such a manner that the original entry is not lost and correction is made 657
close to the original entry, initialed and dated. 658
d) that documents bearing instructions are clearly written step by step. 659
e) documents are dated and authorised 660
f) documents are readily available to relevant parties. 661
662
7.2 Specifications 663
664
7.2.1 The organisation shall ensure that all specifications are approved by authorised 665
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personnel. 666
667
7.2.2 The organisation shall ensure that raw and packaging material specifications include: 668
a) Name of material 669
b) Description of material 670
c) Testing parameters and acceptance limits 671
d) Technical drawings, where applicable 672
e) Special precautions, if necessary 673
674
7.2.3 The organisation shall ensure that bulk and finished product specifications include: 675
a) Name of product 676
b) Description 677
c) Physical properties 678
d) Chemical assay and/or microbiological assays and their acceptance limits; if necessary. 679
e) Storage conditions and safety precautions, if necessary. 680
681
7.3 Documents for Production 682
683
7.3.1 Master Formula 684
685
The organisation shall ensure that the Master formula is available upon request. This 686
document should contain the following information: 687
a) Product name and product code/number 688
b) Intended packaging materials and storage conditions 689
c) List of raw materials used, whether they remain unchanged or become altered. 690
d) List of raw materials used. 691
e) List of equipment used. 692
f) In-process controls with their limits in processing and packaging, where applicable. 693
694
7.3.2 Batch Manufacturing Record 695
696
The organisation shall ensure that Batch Manufacturing Record (BMR) is prepared for each 697
batch of product. 698
699
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Each BMR should include the following: 700
a) Name of product 701
b) Batch formula 702
c) Brief manufacturing process 703
d) Batch or code number 704
e) Date of the start and finish of processing and packaging 705
f) Identity of individual major equipment and lines or location used 706
g) Records of cleaning of equipment used for processing as appropriate 707
h) Packaging line clearance inspection records 708
i) Any sampling performed during various steps of processing 709
j) Any investigation of specific failure or discrepancies 710
k) Results of examinations on packed and labeled products 711
712
7.3.3 Records for Quality Control 713
714
The organisation shall ensure that records for each testing, assay result and release or 715
rejection of starting materials, intermediates, bulk and finished product are maintained. 716
717
These records may include: 718
a) Date of test 719
b) Identification of the material 720
c) Supplier name 721
d) Date of receipt original batch number if any 722
e) Batch number 723
f) Quality control number 724
g) Quantity received 725
h) Date of sampling 726
i) Quality control results 727
728
729
8 INTERNAL AUDITS 730
731
An internal audit consists of an examination and assessment of all or part of a quality system 732
with the specific purpose of improving it. An internal audit may be conducted by outside or 733
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independent specialists or a team designated by the management for this purpose. Such 734
audits may also be extended to suppliers and contractors, if necessary. A report should be 735
made at the completion of each quality audit. 736
737
738
9 STORAGE 739
740
9.1 Storage Areas 741
742
9.1.1 The organisation shall ensure that storage areas are of sufficient capacity to allow 743
orderly storage of the various categories of materials and products such as starting and 744
packaging materials, intermediates, bulk and finished products, products in quarantine, and 745
released, rejected, returned or recalled products. 746
747
9.1.2 The organisation shall ensure that storage areas are designed or adapted to ensure 748
good storage conditions. They should be clean, dry and well-maintained. Where special 749
storage conditions are required (temperature and humidity) these should be provided, 750
checked and monitored. 751
752
9.1.3 The organisation shall ensure that receiving and dispatch bays protect materials and 753
products from weather. Reception areas should be designed and equipped to allow 754
incoming materials to be cleaned if necessary before storage. 755
756
9.1.4 The organisation shall ensure that storage areas for quarantine products are clearly 757
demarcated. 758
759
9.1.5 The organisation shall ensure that the sampling area for starting materials is 760
provided to prevent contamination. 761
762
9.1.6 The organisation shall ensure that hazardous materials are safely and securely 763
stored. 764
765
9.2 Stock Handling and Control 766
767
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9.2.1 Receiving Products 768
769
9.2.1.1 The organisation shall ensure that each incoming delivery is checked against the 770
relevant documentation and physically verified by label description, type and quantity upon 771
receipt. 772
773
9.2.1.2 The organisation shall ensure that the consignment is carefully inspected for defects 774
and damage. Records should be retained for each delivery. 775
776
9.2.3 Control 777
778
9.2.3.1 The organisation shall ensure that records are maintained showing all receipts and 779
issues of products. 780
781
9.2.3.2 The organisation shall ensure that the principle of stock rotation (first in – first out) 782
is observed. 783
784
9.2.3.3 The organisation shall ensure that all labels and containers of products are not 785
altered, tampered or changed. 786
787
788
10 CONTRACT MANUFACTURING AND ANALYSIS 789
790
10.1 The organisation shall ensure that the conditions of contract manufacturing and 791
analysis are clearly defined, agreed, and controlled so as to avoid misunderstandings, which 792
could result in a product or work of unsatisfactory quality. All aspects of contracted work 793
should be specified to obtain a quality product conforming to the agreed standards. 794
795
10.2 The organisation shall ensure that there is a written contract between the principal 796
and the contract manufacturer to clearly establish the duties and responsibilities of each 797
party. 798
799
800
11 COMPLAINTS 801
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802
11.1 The organisation shall ensure that there is a person designated to handle complaints 803
and decide on measures to be taken. 804
805
11.2 The organisation shall ensure that there are written procedures describing the 806
action to be taken, including the need to consider a recall, in the case of a complaint 807
involving a possible product defect. 808
809
11.3 The organisation shall ensure that complaints involving product defect are recorded 810
with all the original details and investigated. 811
812
11.4 If a product defect is discovered or suspected in a batch, the organisation should 813
ensure that other batches are checked in order to determine whether they are also affected. 814
In particular, other batches that may contain reprocessed products from the defective batch 815
should be investigated. 816
817
11.5 The organisation should ensure that appropriate follow-up action, possibly including 818
product recall, are taken after investigation and evaluation of the complaint. 819
820
11.6 The organisation shall ensure that all the decisions and measures taken as a result of 821
a complaint are recorded and referenced to the corresponding batch records. 822
823
11.7 The organisation shall ensure that complaint records are regularly reviewed for an 824
indication of specific or recurring problems that require attention and might justify the recall 825
of marketed products. 826
827
11.8 The organisation shall ensure that the complaint authority is informed if a 828
manufacturer is considering action following possibly faulty manufacture and product 829
deterioration, which may lead to serious safety issues. 830
831
12 PRODUCT RECALLS 832
833
12.1 The organisation shall ensure that there is a system of recall from the market of 834
products known or suspected to be defective. 835
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836
12.2 The organisation shall ensure that there is a designated person responsible for the 837
execution and co-ordination of recalls, as well as sufficient personnel to handle all aspects of 838
recalls with the appropriate degree of urgency. 839
840
12.3 The organisation shall ensure that there is written procedures for recall that are 841
reviewed regularly. Recall operations should be capable of being initiated promptly. 842
843
12.4 The organisation shall ensure that the primary distribution records are readily 844
available to the person(s) responsible for recalls, and they should contain sufficient 845
information of distributors. 846
847
12.5 The organisation shall ensure that the progress of the recall process is recorded and 848
a final report issued, including reconciliation between the delivered and recovered 849
quantities of the products. 850
851
12.6 The organisation shall ensure that the effectiveness of the arrangements for recalls 852
is evaluated from time to time. 853
854
A written instruction should be established to ensure recalled products are stored securely 855
in a segregated area while awaiting decision. 856
857
858
13 LEGAL REQUIREMENTS 859
860
The organisation shall ensure that all activities and products shall in other aspects comply 861
with the requirements of the relevant legislations currently in force. 862
863
864
14 MARKING 865
866
The organisation shall ensure that there is a clearly recognisable HALAL mark in accordance 867
with the Halal requirements on the product itself and/ or packaging. 868
869
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870
15 HALAL COSMETICS AND PERSONAL CARE CERTIFICATION 871
872
15.1 Organisation 873
874
In order to be Halal certified, all Halal cosmetics and personal care manufacturers shall be 875
audited by a competent authority and certified by a recognised Halal certification body. In 876
the event where Halal and non-Halal cosmetic is prepared within the same premise, then 877
only the area where Halal cosmetic and personal care is prepared or served may be certified 878
provided sufficient segregation is implemented. 879
880
15.2 Compliance 881
882
For finished products deemed to conform to this standard, it shall comply with Clauses 4 to 883
15 of this standard. This shall be verified through inspection by an accredited Halal 884
Certification body. 885
886
15.3 Certification mark 887
888
A facility and service, upon approval by a recognised Halal certification body, may be 889
accompanied with a Halal certificate of that authority provided the facility and/or service 890
conforms to the requirements of this standard. 891
892
For a dedicated Halal facility, the Halal certificate may appear on the outside of the facility. 893
For a non-dedicated Halal facility, the Halal certificate shall not be displayed. The Halal 894
certificate shall be kept in the office and shall be made available up on inspection by an 895
accredited Halal Certification Body. 896
897