Quyết định 3339/2001/QD-BYT

Nội dung toàn văn Decision No.3339/2001/QD-BYT on issuing provisions for hygiene for some plastic

MINISTRY OF HEALTH -------	SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom – Happiness ---------
No.: 3339/2001/QD-BYT	Hanoi, July 30, 2001

DECISION

ON ISSUING "PROVISIONS FOR HYGIENE FOR SOME PLASTIC PACKING USED FOR PACKAGING, CONTAINING FOOD"

Pursuant to the Decree No.68/CP dated 11/10/1993 of the Government stipulating the function, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Decree No.86/CP dated 08/12/1995 of the Government assigning responsibilities of state administration for goods quality;

Pursuant to the Decision No.14/1999/QD-TTg dated 04/02/1999 of the Prime Minister on establishment of Department for Quality Management, Hygiene and Food Safety;

At the proposal of the Office Chief, Director of Department of Science and Training, Director of Legal Department, the Chief Inspector - Ministry of Health and Director of Department for Management of quality, hygiene and food safety,

DECIDES:

Article 1. Issue together with this Decision the "Provisions for Hygiene for Some Plastic Packing Used for Packaging, Containing Food"

...

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Article 3. Mr./Ms: Chief Office, Chief Inspector, Directors of Departments: Science and Training, Legislation, Preventive Medicine - Ministry of Health, Director of Quality Management of hygiene and food safety, Health Director of provinces, the centrally-run cities and the heads of units under the Ministry of Health shall implement this Decision./.

FOR MINISTER OF HEALTH
DEPUTY MINISTER

Le Van Truyen

PROVISIONS

FOR HYGIENE, SAFETY FOR SOME PLASTIC PACKINGS USED FOR PACKAGING, CONTAINING FOOD
(Issued together with Decision No.3339 /2001/QD-BYT, dated July 30, 2001 of Minister of Health)

1. General provisions

1.1. Scope of governing

...

1.2. Subjects of application

These provisions apply to individual business households and enterprises of all economic sectors producing and trading plastic packing used for packaging, containing food.

1.3. In these provisions, the following terms are construed as follows:

Plasticizers are the organic compounds of high molecular produced by polymerization process, or the similar processes from the molecules with lower volumes. Plasticizers are also made from natural polymers or denatured natural polymer.

Specific migration limit: is the movement of substances in the packing into food.

2. Requirements on hygiene, safety for food packing made of plastics

2.1. General requirements

2.1.1. Plastic food packing is not leaked substances to food with concentrations exceeding 10 mg/dm² of surface area of packing.

Specific migration limit is 60 mg/kg of food for the following cases:

...

- Packing that is difficult to determine the surface in contact with food;

- All kinds of capsules, washers, buttons, caps.

2.1.2. Plastic packing used to contain oil, grease, and milk circulated on the market is only used once.

2.2. Requirements for the monomers and other starting substances

Safety limits of the monomers and other starting substances used in manufacturing food packing of plastic must comply with requirements specified in Table 1.

2.3. Requirements for additives

The additives used in manufacturing food packing of plastic must comply with requirements specified in TCVN 6514-8: 1999 (AS 2070-8: 1992 (E)).

2.4. Requirements for pigments

The pigments used in manufacturing food packing of plastic must comply with requirements defined in TCVN 6514-6: 1999 (AS 2070-6: 1995 (E)).

...

In addition to the requirements specified in section 2 of these Provisions, the test conditions and safety limits for finished materials and packing as PE, PP must comply with requirements specified in Table 2.

4. Requirements for food packing as polyethylene terephtalat (PET)

In addition to the requirements specified in section 2 of these Provisions, the test conditions and safety limits for finished materials and packing as PET must comply with requirements specified in Table 3.

5. Requirements for food packing as polyvinyl chloride (PVC)

In addition to the requirements specified in section 2 of these Provisions, the test conditions and safety limits for finished materials and packing as PVC must comply with requirements specified in Table 4.

Table 1. Safety limits of the monomers and other starting substances used in manufacturing food packaging of plastic

No.

Names of substances

Safety limits

...

Acrylamit

SML = 0,01 mg/kg

SML = 0,05 mg/kg

DL = 0,02 mg/kg

...

SML(T) = 6 mg/kg

SML = 12 mg/kg

...

QMA = 0.05/6 dm²

SML = 0.05 mg/kg

...

QM = 5 mg/kg

SML = 0.05 mg/kg

...

SML = 5 mg/kg

QMA = 0.05 mg/6 dm²

...

DL = 0.01 mg/kg

...

SML = 0.05 mg/kg

DL = 0.01 mg/kg

SML = 5 mg/kg

...

SML = 0.05 mg/kg

...

SML(T) = 30 mg/kg

...

SML = 0.05 mg/kg

...

QM(T) = 5 mg/kg in FP

...

SML = 0.05 mg/kg

SML = 7.5 mg/kg

...

DL = 1 mg/kg in FP

DL = 0.01 mg/kg

...

SML(T) = 6 mg/kg

...

100

SML = 0.05 mg/kg

101

102

SML = 7.5 mg/kg

103

SML(T) = 7.5 mg/kg

...

QM(T) = 5 mg/kg in FP

105

106

107

SML = 0.05 mg/kg

108

SML(T) = 30 mg/kg

...

SML = 6 mg/kg

110

SML = 0.05 mg/kg

111

SML = 0.05 mg/kg

112

113

SML = 3 mg/kg

...

SML(T) = 1 mg/kg

115

116

QM(T) = 1 mg/kg in FP (calculated by NCO)

117

SML = 0.05 mg/kg

118

SML = 1.8 mg/kg

...

SML = 3 mg/kg

120

SML(T) = 1 mg/kg

121

SML = 0.05 mg/kg

122

123

QM = 1 mg/kg trong FP (calculated by NCO)

...

125

126

QM = 1 mg/kg in FP (calculated by NCO)

127

128

...

130

131

132

SML = 0.05 mg/kg

133

...

135

SML(T) = 15 mg/kg

136

SML(T) = 15 mg/kg

137

138

...

QM = 1 mg/kg trong FP

140

141

QM = 1 mg/kg trong FP

142

QMA = 0.05 mg/6 dm²

143

...

145

146

SML = 0.05 mg/kg

147

148

SML = 0.05 mg/kg

...

150

SML = 12 mg/kg

151

SML = 2.4 mg/kg

152

QM(T) = 1 mg/kg in FP (calculated by NCO)

153

SML(T) = 30 mg/kg

...

SML = 5 mg/kg

155

SML = 0.05 mg/kg

156

SML = 6 mg/kg

157

SML = 2.4 mg/kg

158

SML = 0.6 mg/kg

...

SML = 6 mg/kg

160

SML = 6 mg/kg

161

SML = 18 mg/kg

162

QM(T) = 1 mg/kg in FP (calculated by NCO)

163

SML = 0.05 mg/kg

...

SML = 0.05 mg/kg

165

166

QM = 1 mg/kg in FP

167

168

QM(T) = 1 mg/kg in FP (calculated by NCO)

...

QM(T) = 1 mg/kg in FP (calculated by NCO)

170

QM(T) = 1 mg/kg in FP (calculated by NCO)

171

172

QM = 1 mg/kg in FP

173

SML = 0.05 mg/kg

...

QM = 1 mg/kg in FP

175

176

177

SML = 12 mg/kg

178

SML(T) = 30 mg/kg

...

DL = 0.01 mg/kg

180

QM = 1 mg/kg in FP

181

SML = 30 mg/kg

182

DL = 0.02 mg/kg

183

SML = 15 mg/kg

...

185

186

187

DL = 0.01 mg/kg

188

...

DL = 0.01 mg/kg

190

SML = 2.4 mg/kg

191

QM(T) = 1 mg/kg in FP (calculated by NCO)

192

SML(T) = 15 mg/kg (calculated by formaldehyd)

193

SML = 0.6 mg/kg

...

SML = 3 mg/kg

195

QMA = 5 mg/6 dm²

196

197

QM = 5 mg/kg in FP

198

...

200

201

SML(T) = 30 mg/kg (calculated by maleic acid)

202

SML = 30 mg/kg

203

DL = 0.02 mg/kg

...

205

DL = 0.02 mg/kg

206

207

QMA = 0.006 mg/6 dm². Only used for polypropylene.

208

DL = 0.01 mg/kg

...

SML = 0.02 mg.kg

210

QM(T) = 1 mg/kg in FP (calculated by NCO)

211

212

213

...

SML = 0.05 mg/kg

215

QM(T) = 1 mg/kg in FP (calculated by NCO)

216

217

218

...

220

221

SML = 0.05 mg/kg

222

223

QM = 1 mg/kg in FP

...

QM = 1 mg/kg in FP

225

226

227

228

...

230

231

232

SML = 0.05 mg/kg

233

...

235

236

237

238

QM = 1 mg/kg in FP

...

240 x

SML = 0,05 mg/kg (calculated by pyromellitic acid)

241

SML = 2.4 mg/kg

242

243

...

245

246

247

248

...

250

251

252

SML = 0.05 mg/kg

253

...

SML = 0.05 mg/kg

255

SML = 0.6 mg/kg

256

257

QM(T) = 1 mg/kg in FP (calculated by NCO)

258

QM(T) = 1 mg/kg in FP (calculated by NCO)

...

QM(T) = 5 mg/kg in FP (calculated by trimellitic acid)

260

SML = 30 mg/kg

261

262

SML = 6 mg/kg

263

...

QM = 0.5 mg/kg in FP. Only used for polycacbonat

265

266

267

QM = 5 mg/kg in FP or DL = 0.05 mg/kg

268

SML = 5 mg/kg

...

QM = 5 mg/kg in FP

270

271

QM = 5 mg/kg in FP

272

QM = 2 mg/kg ing FP

273

...

1,4-Xyclohexandimetanol

275

Xyclohexyl isocyanate

QM(T) = 1 mg/kg in FP (calculated by NCO)

Notes:

OM (overall migration limit): overall migration limit, not exceeding 60 mg/kg of food or 10 mg/dm2 of surface area of packing.

DL (detection limit of the method of analysis): detection limit of the method of analysis

FP (finished material and article): Finished Packing.

...

SML (specific migration limit in the foods or in a food simulant): specific migration limit of monomers/substances

SML (T) (The specific migration limit in foods or in a food simulant as a total of moiety/substances indicated): specific migration limit of monomers group/substances

QM (Maximum permitted quantity of the “residual” substance in the material or article): maximum permitted residues of monomers/substances

QM (T) (Maximum permitted quantity of the “residual” substance in the material or article expressed as total of moiety/substance(s) indicated): maximum permitted residues of monomers group/substances

QMA (Maximum permitted quantity of the monomer/substance in the finished material or article expressed as mg/6 dm2 of the surface in contact with foodstuffs): Maximum permitted specific migration limit of the monomers/substances in finished packing is calculated according to mg/6 dm2 of surface in contact with food.

Table 2. Test conditions and safety limits for finished materials and packing as PE, PP

Examination of materials

Cadmium

Not exceeding 100 mg/kg

...

Not exceeding 100 mg/kg

Examination of finished packing

Examination criteria

Conditions of soak

Soak solution

Safety limits

Heavy metals

60oC in 30 mins

acetic acid 4%*1

...

Volume of KMnO4 used

Water*2

Not exceeding 10 mg/kg

Dry residue

25oC in 60 mins

n-Heptane*3

Not exceeding 30 mg/kg (Not exceeding 150 mg/kg if used at 100oC or smaller)

60oC in 30 mins

Ethanol 20%*4

...

Not exceeding 30 mg/kg

Water*2

acetic acid 4%*1

Note:

*1: For foods with pH  5

*3: For foods with oil, grease, fat

*2: For foods with pH 5

*4: For beverage with alcohol

...

Examination of materials

Cadmium

Not exceeding 100 mg/kg

Lead

Not exceeding 100 mg/kg

Examination of finished packing

Examination criteria

Conditions of soak

Soak solution

...

Heavy metals

60oC in 30 mins

acetic acid 4%*1

Not exceeding 1 mg/kg

Antimony

Not exceeding 0.05 mg/kg

Germanium

Not exceeding 0.05 mg/kg

Volume of KMnO4 used

...

Not exceeding 10 mg/kg

Dry residue

25oC in 60 mins

n- Heptane*3

Not exceeding 30 mg/kg

60oC in 30 mins

Ethanol 20%*4

...

Water *2

acetic acid 4%*1

Note:

*1: For foods with pH  5

*3: For foods with oil, grease, fat

*2: For foods with pH 5

*4: For beverage with alcohol

Table 4. Test conditions and safety limits for finished materials and packing as PVC

Examination of materials

...

Not exceeding 100 mg/kg

Lead

Not exceeding 100 mg/kg

dibutyl tin compounds

Not exceeding 50 mg/kg

Cresol phosphate

Not exceeding 1000 mg/kg

Vinyl chloride

Not exceeding 1 mg/kg

...

Examination criteria

Conditions of soak

Soak solution

Safety limits

Heavy metals

60oC in 30 mins

acetic acid 4%*1

Not exceeding 1 mg/kg

Volume of KMnO4 used

...

Not exceeding 10 mg/kg

Dry residue

25oC in 60 mins

n- Heptane*3

Not exceeding 150 mg/kg

60oC in 30 mins

...

Not exceeding 30 mg/kg

Water*2

acetic acid 4%*1

Note:

*1: For foods with pH  5

*3: For foods with oil, grease, fat

*2: For foods with pH 5

*4: For beverage with alcohol

...

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Thuộc tính Văn bản pháp luật 3339/2001/QD-BYT
Loại văn bản	Quyết định
Số hiệu	3339/2001/QD-BYT
Cơ quan ban hành	Bộ Y tế
Người ký	Lê Văn Truyền
Ngày ban hành	30/07/2001
Ngày hiệu lực	...
Ngày công báo	...
Số công báo
Lĩnh vực	Thể thao - Y tế
Tình trạng hiệu lực	Không xác định
Cập nhật	2 năm trước
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Decision No.3339/2001/QD-BYT on issuing provisions for hygiene for some plastic
Loại văn bản	Quyết định
Số hiệu	3339/2001/QD-BYT
Cơ quan ban hành	Bộ Y tế
Người ký	Lê Văn Truyền
Ngày ban hành	30/07/2001
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Số công báo
Lĩnh vực	Thể thao - Y tế
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