QS Audit Rules for Plastic Bottles and Other Packaging Products

Supplementary Explanations by the Professional Committee on the General Rules and Detailed Rules for Food Packaging Materials

Serial No. Subject Clause No. Relevant clause Explanation (modification) content 1 "General Rules" Application materials submitted by enterprises Clause 3.1.2 Supplement: photocopy of the enterprise organisation code certificate and the filed enterprise standard.

2 3.1.2 .2 Photocopy of the business licence When a food production enterprise applies for a production licence for plastic packaging containers, tools and other products for food use, and the business scope of its business licence covers only the food it produces, no requirement is imposed on the

food-use plastic packaging containers, tools and other products it produces for its own use.

3 3.1.2 .3 Certification documents meeting the requirements issued by the local environmental protection department. The requirements for environmental protection certification are relaxed; any of the following is acceptable: (1) the environmental protection department's approval opinion on the enterprise's construction project made on the basis of the environmental impact assessment report, and its acceptance opinion after the plant is built; (2) the pollutant discharge permit and certification that noise meets the requirements; (3) the environmental monitoring report.

4 3.1.2 .7 Product type inspection report.

(1) The type inspection report may be completed by the enterprise itself or entrusted to a qualified inspection body, but it must cover the same batch of products, that is, all items must be reflected in a single report.

(2) If the enterprise cannot provide the type inspection report at the verification site, the verification team shall continue the on-site verification work, but the enterprise shall submit the type inspection report within the prescribed time; otherwise the submitted materials shall be deemed incomplete.

5 3.1.2 .8 Product instructions for use or product label.

Enterprises may, according to the characteristics of their own products, state the content that affects personal health and safety; other content that is self-evident may be simplified, but users must not be inconvenienced or harmed as a result of the simplification of the instructions or label.

6 3.2.2 Products trial-produced by an enterprise must be inspected batch by batch by an inspection body designated by the General Administration of Quality Supervision, Inspection and Quarantine in accordance with the provisions of the corresponding product detailed rules.

The 8 licence-issuing inspection bodies designated by the General Administration carry out batch-by-batch inspection of factory-exit inspection items. "Products trial-produced by an enterprise" include the products of newly established enterprises and additional products of certified enterprises.

7 Where an enterprise does not have the testing capability for key control inspection items, it shall send samples every 3 months to an inspection body designated by the General Administration of Quality Supervision, Inspection and Quarantine for inspection.

Inspection bodies designated by the General Administration of Quality Supervision, Inspection and Quarantine refer to the licence-issuing inspection bodies designated by Document No. 86.

8 7.6 The enterprise has non-conforming items in product inspection during spot checks, supervisory inspections or when complaints are made about its quality. The "spot checks and supervisory inspections" stipulated above are provincial-level supervisory spot checks, periodic supervisory spot checks by prefectures and cities, national supervisory spot checks, special inspections, etc.

9 "Detailed Rules" On-site verification measures Requirements for production enterprises that carry out only part of the processes, such as bag-making plants, sub-packaging plants and assembly plants 1. The requirements for on-site verification, production equipment, inspection equipment, etc. cover only the content involved in that process.

1. For such enterprises, the production licence certificate will indicate the limited process among the product varieties.
2. For bag-making plants and sub-packaging plants: the type inspection report of their upstream enterprises' products may be accepted; after the on-site verification is passed, samples must be taken for licence-issuing inspection.

2.2.8 The workshop shall establish separate passages for personnel entry and exit and for material flow; entry of personnel shall be provided with disinfection, dust removal or air shower (bath) devices, and work clothing shall be kept clean. All enterprises producing plastic packaging containers, tools and other products for food use shall have passages for personnel entry and exit and for material flow, and the personnel passage shall have changing, disinfection and dust removal facilities. The material flow passage shall be isolated from the production area and shall have an isolation zone suited to production. Personnel transporting materials shall not enter the production area, and production area staff shall not enter or leave through the material flow passage.

Disinfection facility requirements for enterprises producing packaging containers, tools and other products that directly package food for direct consumption, such as cling film, laminated film, disposable tableware, beverage bottles or drinking water buckets: hand-washing facilities shall be sensor-operated or foot-operated to avoid cross-contamination; disinfection shall be carried out, for example with alcohol. Buffer zones shall be regularly disinfected by ultraviolet irradiation. Work clothing shall include hats and gloves (if it is inconvenient to wear gloves while working, the hands shall be disinfected at regular intervals during work), full-body work clothing, and a change of shoes or foot covers. Air shower facilities shall also be provided (beverage bottle or drinking water bucket producers may use air curtains combined with positive pressure in the plant).

Enterprises producing packaging containers, tools and other products not for direct consumption, such as melamine tableware and plastic chopping boards, shall at least wash hands with liquid soap and shall at least have dust removal facilities such as dust removal rollers. Clean work clothing shall be worn. For the following three categories of products, air showers are mandatory: (1) cling film (2) disposable tableware (3) laminated film bags. Changing and hand-washing facilities are mandatory and shall be located at the entrance to the production area.

10 "Detailed Rules" On-site verification measures 2.3 Production facilities 1. Enterprises must have workplaces and production facilities that meet production needs, and maintain them in good condition.

1. There shall be cleaning, disinfection, dust-proofing, anti-corrosion, ventilation and waste treatment facilities suited to the products produced, maintained in good condition. Production facilities do not include production equipment; they mainly refer to facilities other than production equipment that are directly related to the normal conduct of production, such as handling facilities, ventilation facilities and material conveying facilities. Workplace means the space and area that ful-

fil the needs of production. Enterprises producing packaging containers, tools and other products that directly package food for direct consumption, such as cling film, laminated film and dispos-

able tableware, shall carry out enclosed production and have ventilation and dust-proofing facilities suited to enclosed production. Enterprises producing packaging containers, tools and other products not for direct consumption, such as melamine tableware and plastic chopping boards, shall also have dust-proofing and ventilation facilities suited to production, such as exhaust fans.

11 3.3.4 Inspection personnel shall be familiar with the product inspection provisions and possess quality and safety knowledge, skills and qualifications suited to their work.

The corresponding qualification means taking up the post after training; the training may be internal or external.

12 5.4 Packaging marking.

For products with a clear food-use purpose, such as baby bottles, drinking cups, tableware and chopping boards, no food-use mark need be added to their packaging label or instructions. For other products that are easily confused with non-food-use products, such as other non-laminated film and laminated film, the words "for food use" shall be indicated on the product packaging or label. For products transferred internally rather than sold externally, if they are products produced on a linked line within the workshop or products that have not left the workshop, the "for food use" mark need not be indicated, whereas products transferred to another location or shipped out with additional packaging must be marked on the outer packaging.

13 6.1 Inspection management It shall be confirmed in the quality and safety management system that "the quality inspection department has the right of veto over product quality"; the quality inspection department shall be able to objectively and truthfully determine whether a product is qualified based on inspection data and issue the corresponding report, and no other personnel may artificially interfere with the determination result.

14 "Detailed Rules" (I) Non-laminated film bags 1. Scope of products subject to licensing Where an enterprise heat-seals ordinary biaxially oriented polypropylene film products and uses them directly to package food, they shall be treated as heat-sealable biaxially oriented polypropylene film. One product variety is added: GB/T 10003-1996 ordinary BOPP film. If an enterprise purchases single film and sells it after printing only, no licence shall be issued for the time being. Where single film is produced and used only for the company's own laminated film production, the single film also requires licence application.

15 4. Product standards and related standards Table 2 For polyvinylidene chloride sheet casing film among non-laminated films, the related standards are supplemented with GB15204-1994 "Hygienic Standard for Vinylidene Chloride-Vinyl Chloride Copolymer Resin for Food Containers and Packaging Materials" 16 7.1 Licence-issuing inspection sampling methods Table 4 Polyethylene self-adhesive cling film: 3 rolls shall be randomly taken; this shall be changed to 6 rolls; commodity retail packaging bags and zipper-style self-sealing bags: 30×2 pieces shall be taken from each of 3 boxes respectively (bag specifications shall be no smaller than 15×15 cm, or some film not yet made into bags shall be taken as a supplement).

17 7.3 Determination rules Cling bags shall be inspected as commodity retail packaging bags; the thickness item shall not be evaluated.

18 "Detailed Rules" (II)

Laminated film bags 1. Scope of products subject to licensing To avoid confusion, the 9th laminated film product, "multi-layer laminated food packaging film and bags", is changed to "other types of laminated food packaging film and bags". Enterprises must have a filed enterprise standard, and the hygiene index requirements in the enterprise standard shall not be lower than the requirements of the national and industry standards and the detailed rules for products of the same type of inner-layer material. Where a colour printing plant purchases laminated film and sells it directly after printing, no licence shall be issued for the time being.

19 2.2.3 Key process control The curing room shall admit air from the lower part and exhaust air from the upper part. There is no requirement as to the form,

only that it does not affect the curing temperature and time.

20 4. Product standards and related standards Table 2 For paper-based composite materials for the fresh-keeping packaging of liquid food (gable-top cartons), the related standards are as set out in the product standards 21 6. Necessary factory-exit inspection equipment Table 3 The necessary factory-exit inspection equipment for other types of multi-layer laminated film bags is changed to 1. tape measure or straight ruler or vernier calliper; 2. material testing machine; 3. magnifying glass 22 7.1.1 Where an enterprise applies for the following 4 kinds of laminated film bag products, 2 products with high technical requirements shall be sampled in descending order of technical requirements for licence-issuing inspection If an enterprise produces all four samples in 7.1.1 at the same time, but at the time of sampling there are no retort-resistant laminated film bags or laminated film bags for pickled mustard tuber packaging in the finished goods warehouse and only the latter two of the 4 kinds of laminated film bags are sampled, then the licensed product varieties shall not include retort-resistant laminated film bags or laminated film bags for pickled mustard tuber packaging, and these shall be handled separately as additional items.

23 7.1. Sampling methods Laminated bags: 30×2 pieces shall be taken from each of 3 boxes respectively (bag specifications shall be no smaller than 15×15 cm, or some film not yet made into bags shall be taken as a supplement). Where microbiological test indicators are involved, samples shall be sealed separately and handed directly to the microbiological testing personnel to avoid contamination during sample transfer.

24 8. Marking of the QS mark An enterprise shall, within 12 months after obtaining certification, print a non-removable QS mark on an appropriate part of its certified product. Changed to: within 12 months after obtaining certification, print a non-removable QS mark on an appropriate part of its certified product, or on the outer packaging box (for bag products) or the paper core (for roll finished products).

25 "Detailed Rules" (IV)

Woven bags 7. Sampling methods If an enterprise claims to produce both plastic woven bags and composite plastic woven bags, but at the time of on-site verification there are no composite plastic woven bag samples and only plastic woven bags are sampled, then only plastic woven bags shall be included among the licensed product varieties, and composite plastic woven bags shall be handled separately as an additional item.

Where an enterprise produces both polyethylene and polypropylene woven bags, samples shall be taken separately.

26 "Detailed Rules" (V)

Container products 1. Scope of products subject to licensing: "plastic baby bottles, plastic drinking cups (jugs), plastic bottle preforms" is changed to "plastic baby bottles, plastic drinking cups (jugs), plastic bottles (preforms)"

Reusable plastic containers of all shapes may be applied for as plastic bottles.

Where bottle preforms are produced for use only in the company's own beverage bottle production, the preforms also require certification, but there is no need to formulate an enterprise standard or carry out type inspection; only process quality control is required.

27 3. Necessary production equipment Table 1 The necessary production equipment for plastic tamper-evident bottle caps, the injection moulding machine, is changed to: injection (compression) moulding machine.

28 6. Necessary factory-exit inspection equipment Table 3 For polyester (PET) non-carbonated beverage bottles, delete: verticality deviation tester.

29 Plastic tamper-evident bottle caps delete: projector 30 For the 1st, 2nd and 3rd products, the graduated cylinder may be replaced by a balance.

31 7.1 Sampling methods Table 4 For polyethylene blow-moulded buckets, the sampling quantity of 20 is changed to: 28 32 8. Marking of the QS mark is changed to: within 12 months after obtaining certification, the enterprise shall itself print (affix) a QS mark on an appropriate part of the mould for its certified product, on the outer packaging, on the label or in the instructions. For products facing consumers directly, such as plastic baby bottles and plastic drinking cups, the QS mark shall be printed (affixed) on their smallest sales packaging, instructions or the product.

When the QS mark is engraved on the mould, it may be colourless.

33 Individual evaluation of inspection items For the three kinds of PET bottles, the vertical load-bearing pressure, and for hot-fill bottles the capacity deviation and minimum wall thickness, only data shall be issued, with no evaluation 34 "Detailed Rules" (VI)

Tools for food use 1. Scope of products subject to licensing 1. Limited to the two materials polypropylene (PP) and polystyrene (PS); 2. Including thermoformed lunch boxes, bowls, plates, saucers, cups and lids made by vacuum forming; 3. Including blow-moulded disposable tableware; 4. Including injection-moulded disposable tableware, such as instant noodle cups and ice cream cups; 5. Excluding yoghurt cups, jelly cups, knives, forks, stirring rods and drinking straws; 6. Excluding various vacuum-formed biscuit trays, vegetable trays, seafood trays, etc.; for such products, if the enterprise itself produces the sheet and then processes it, it may

first apply for the production licence for the sheet in accordance with the detailed rules.

35 4. Product standards and related standards Table 6 For disposable plastic tableware, the product standards and related standards are supplemented with: GB 18006.1-1999 General Technical Conditions for Disposable Degradable Tableware 36 6. Necessary factory-exit inspection equipment Table 9 For disposable plastic tableware, delete the metal plug gauge and the Shore hardness tester 37 7.1 From the warehouse of the production enterprise, one specification of the leading product shall be randomly taken for licence-issuing inspection. Products of the same raw material, the same specification and the same process constitute one batch. From the finished goods warehouse of the production enterprise, one specification of the leading product shall be randomly taken from each product variety for licence-issuing inspection. Products of the same raw material, the same specification and the same process constitute one batch.

38 7.1.3 Sampling methods For disposable plastic tableware, add: if there are different materials, each material must be sampled.

39 7.2 Inspection items For disposable plastic tableware, for the licence-issuing inspection item of the temperature resistance performance of polystyrene (PS), only the test data may be reported, without individual evaluation.

——This article is reprinted from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-362235.html