Global Supplier Standards for SCA hygiene business English

8/7/2019 Global Supplier Standards for SCA hygiene business English

1/32

Globl Spplie Stddfor sc hgene bsness januar 2 011


2/32

Itodctio3 Qlity

4 Podct sfety

4 Eviomet

4 Code of Codct4 Spplie evltio d complice

Qlity5 Qlity mgemet system

6 resoce mgemet

6 Podct elistio

9 Mesemet, lysis d impovemet

Podct sfety10 Podct sfety ssessmet

11 restictios11 Cotmitio pevetio d hygiee cotol

Eviomet13 Eviometl mgemet system

13 Eegy d cbo

14 Eviometl qestioies

14 Plp

15 Occptiol helth d sfety

Chemicls

16 Chemicl legisltio16 Chemicls of specil coce

Code of Codct17 ntiol lws d egltios

17 Helth d sfety

17 Employee eltios

18 Bsiess pctice

18 respect fo hm ights

18 Commity eltios

18 Commictio d pivcy of dt

18 Gievce/Complit pocede18 Eviomet

aexes20 a 1 Hygiee cotol

22 a 2 Hzd lysis d cotmitio pevetio

24 a 3 Chemicls of specil coce

27 a 4 Legisltio d abbevitios

Globl SpplieStddfor sc hgene bsness

januar 2 011

1

2

3

4

5

6

For SCA Hygiene Businessjy 2011

Designed and produced by:Itellect Ifolog, Stockholm 2011 3467

Pited o Mke Lyx, podct with

FSC cetifictio.

Images: SCa, Getty Imges, iStockphoto.


3/32

SCA strongly believes that our performance and recognition as a sustainable

business partner to customers and consumers require high standards in the areasof quality, product safety, environment and social responsibility.

We realise that our ability to actively and constantly raise our standards dependson the supplier base we select for our products. SCA is recognised for its sustain-

able business, and in our position as a leading hygiene company we shall manageand drive not only our own performance, but also develop the performance of

our suppliers. SCA believes that working together with our suppliers for a moresustainable business will create a positive result for both parties.

The Supplier Standard for SCA hygiene business is based on internationally

recognised standards and management systems, but it also includes specic re-quirements for SCA hygiene business.

We are committed to continually improving our total performance in the areascovered by the Supplier Standard. Consequently, in our supplier selection proc-

ess, supplier performance, improvement and commitment in these areas will playan important role.

You are invited to join us on this journey towards continually higher standards

for SCA hygiene business and for your own business. Together with our suppli-ers we shall provide products that we can all be proud of while fullling the highstandards of SCA.

Anders AronssonVice President Sourcing

SCA Global Hygiene Sourcing

Pefce


4/32


5/32


6/32

n Preventive action to avoid defects ispreferable to quality inspection and

correctionn Any defect detected should lead to a

corrective and preventive action

pu ay

Product safety is dened as safety for usersand others who come in contact with SCA

hygiene businesss nal products. SCA hy-giene business works systematically with

product safety to ensure its nal productsare safe for customers, consumers and

others to use and handle. A signicantpart of this is to guarantee that the ma-terials delivered are safe. Critical aspects

are e.g. chemical composition, includingchemical impurities, and control of gen-

eral and microbiological contaminationduring the production of materials.

evi

For SCA hygiene business, environmentalissues are part of the broader concept ofsustainability.

Sustainability refers to economicgrowth and social and environmental

care, which enables society to meet theneeds of the present without compromis-

ing the needs of future generations.With regard to environmental man-

agement systems, this supplier standard is

based on the principles set out in the ISO14001 standard. Other environmental

requirements are based on SCA hygienebusinesss environmental strategies and

objectives.

c cu

SCA has dened and adopted a corporate

Code of Conduct. This Code of Conductdenes the principles that SCA regards as

fundamental for sustainable developmentand socially responsible behaviour. It ad-dresses such issues as health and safety,

employee relations, human rights, busi-ness ethics and community involvement.

SCA expects that its suppliers conducttheir business to the same high standards.

sui vauai a ia

Material selection and supplier selectionare two distinct processes at SCA hygienebusiness. Both material and supplier must

be evaluated before supply to SCA hy-giene business can be authorised.

If the relationship between SCA hy-giene business and the supplier is new,

an initial evaluation is conducted to as-sess the potential suppliers ability to meet

SCA hygiene businesss requirements.Such an assessment can take the form of aquestionnaire, visit or a formal audit.

When areas of non-compliance areidentied at a supplier, corrective action

has to be implemented and the time framefor reaching compliance agreed upon.

SCA hygiene business believes in work-ing together with the supplier to improveperformance.

The expectations of compliance canalso be reinforced in contracts.

Follow-up audits and visits may be car-ried out to continually evaluate and im-

prove supplier performance.

1aGE

4


7/32

maa y a so 9001

SCA hygiene business requires that suppliers implement a Quality Management Systemthat conforms to all requirements in the current ISO 9001 standard. The preferred level

is an ISO 9001 certication.In addition to the requirements of the ISO 9001 standard, the supplier should comply

with the following requirements.

Qlt mngement sstem

rELaES O SECIOn 4 OF HE ISO Sanar aIIOnaL rEQuIrEMEnS

duai qui

Control of quality records

Quality records shall be kept available for evaluation by SCA hygiene business for aperiod of ve years after delivery of the material. As a minimum, these records should

includen Specication of the material deliveredn Quality control data/certicates of analysis to prove conformity of the material

deliveredn Traceability of raw materials/components used for production of the material

delivered

2 Qlity


8/32

resorce mngement


hua u

CompetenceRelevant parts of the suppliers organisation shall have a good understanding, with

a global perspective if necessary, of the following:n Products, process and quality assurance in the suppliers eld of technologyn Suppliers competitors and their productsn Patents and other intellectual property in the suppliers own eld of technologyn Hygiene products and markets

prodct relston


cu-a

Interaction with SCA hygiene businesss development activities

Suppliers shall ensure that relevant persons in their organisations receive information

about and understand the interactions between their own development activities andthose of SCA hygiene business.

Customer communication

Suppliers shall document their interaction processes with SCA hygiene business.

Each supplier shall appoint a suitably qualied individual to act as SCA hygiene busi-ness coordinator for agreements, orders, customer satisfaction and feedback, claims,

queries and corrective actions.A technical contact person shall be appointed. The contact person shall be respon-

sible for ongoing technical activities and shall be authorised to communicate and takedecisions directly with SCA hygiene business.

The roles of technical contact person and SCA hygiene business coordinator can be

lled by the same individual if desired. He or she should be able to communicate well inEnglish and be able to travel to SCA hygiene business facilities. Local communication

between supplier and SCA hygiene business could be in the local language.The supplier shall identify a contact person or persons for product safety and envi-

ronmental-related information.The content of agreements with and feedback from SCA hygiene business shall be

communicated to relevant internal functions.

Upon request, the supplier shall communicate the plans for and status of activitiesperformed in cooperation with or on behalf of SCA hygiene business.

Suppliers are expected to proactively present new developments.SCA hygiene business expects its suppliers to respond to any queries within a reason-

able period of time.

Specifications

All materials must be dened by an agreed specication or technical data sheet, and witha unique identication code, during regular supply and when in development phases.

aGE

6

2


9/32

During the development phase, the identi-

cation can be temporary.Suppliers may not make any changes

in raw materials/components used, and/or in their processes, including changesof production unit or line, unless such

changes have been communicated to andaccepted by SCA hygiene business before

implementation. This also applies duringthe development phase. SCA hygiene busi-

ness must be notied a minimum of threemonths but preferably six months in ad-vance if any such changes relating to com-

mercially delivered material take place.A new material identity shall be used

if raw materials or process conditionsare signicantly changed, particularly if

the changes may inuence the materialschemical composition.

di a v

Planning

The development and launch of new ma-terials shall follow a documented cross-

functional process. The process descrip-tion shall include:n

How the customers expectations aredetermined

n How material in the developmentalphase is transferred to regular produc-tion

n How parameters necessary for repeti-tive production of a material in the

developmental phase are documented,e.g. material composition, process

parameters

When requested by SCA hygiene business,

a formal agreement on the scope and goalsof a development project shall be made be-

tween the supplier and SCA hygiene busi-ness.

A separate condentiality agreementmay also be required.


10/32

Development outputs

The initial stage of projects to develop new materials shall include the following con-siderations:n Process capability analysis, also valid for pilot machines when applicablen Patents and other intellectual propertyn Cost analysisn Regulatory and product safety aspectsn Environmental aspectsn Occupational health and safety aspects

pui a vi vii

Production

The supplier shall ensure that production and servicing processes are implemented un-

der controlled conditions including the following:n Process results shall be continuously controlled toward the target value for each

property. Where applicable, automatic feedback and control systems and/orstatistical process control (SPC) shall be implemented. Process variations shall be

evaluated continually and the causes of uncontrolled variations eliminated.n Suitable preventive maintenance of equipment shall be carried out to ensure con-

tinuous process capability.n Process capability (Cpk/Ppk) calculations shall be completed and documented

when applicable.

aGE

8

2


11/32

Hygiene control and product safety

Documented procedures shall be established for hygiene control and product safety (SeeChapter 3 and Annex A1).

Hazard analysis for material contamination risks shall be performed and document-ed when required by SCA hygiene business (see Chapter 3 and Annex A2).

Identification and traceability

Material identication shall be recorded in a manner that permits relevant recall proce-

dures. The supplier shall establish and maintain procedures that allow the traceabilityof raw materials/components used in material batches.

The supplier shall perform and document an internal audit of the traceability system(once a year at a minimum), covering both traceability of raw materials used and trace-ability of material produced and delivered.

Traceability records needed to identify delivered material, which have a risk of non-conformity, shall be delivered to SCA hygiene business on demand and in critical situ-

ations on short notice.

Transport

Vehicles must be suitable for hygiene product transportation and should be regularly

cleaned and inspected to ensure that they are free of odours and contamination. Allvehicles, regardless of source, shall be inspected before loading and records of inspec-tion kept.

mesrement, nlss nd mproement

rELaES O SECIOn 8 OF HE ISO Sanar- aIIOnaL rEQuIrEMEnS

ga

Statistical techniques

Procedures established for selection and application of statistical techniques shall in-clude the use of Cpk/Ppk for capability studies.

mii a au

Internal audit

Internal audits shall cover the requirements of the Global Supplier Standard for SCA

hygiene business.

Monitoring and measurement

Personnel performing tests on material properties must be procient in using test meth-ods. Test methods used should be well dened and documented, and preferably recog-

nised standard methods for the specic industry. All measuring instruments must becalibrated and checked in a metrology system.


12/32


13/32

n Information on restricted substancesn Product information le, according to EU cosmetics legislation

If the supplier prefers, a condentiality agreement can be signed restricting the use of

the information to the persons responsible for performing the product safety assess-ment, and only for the purpose of assessing health and safety aspects of the material.

rii

Substances subject to special restrictions are listed in Annex A3.There may be specic documentation requirements for certain materials containing

substances listed in Annex A3. These requirements are specied in separate Require-ment documents.

caiai vi a yi

The production of materials for SCA hygiene business shall take place under controlled

conditions. These shall include contamination prevention and controlled hygiene condi-tions in material production and in the handling of raw materials as well as intermediate

and nished goods.Production of materials shall follow the current GMP (Good Manufacturing Prac-

tice) applicable for the type of material (e.g. for cosmetics or food contact).

The supplier is expected to meet standards for hygiene control see Annex A1.

When required by SCA hygiene business, the supplier must perform hazard analysis

and contamination prevention see Annex A2. This will be required for suppliers of,for example:n Materials to be included in personal care products and selected tissue productsn Ready-made products for personal hygienen Cosmetic products


14/32

aGE

2

4


15/32

SCA hygiene business considers it important to assess the environmental impact of itsproducts during their life cycle. This in turn requires commitment and transparency

from suppliers.Suppliers must comply with relevant legislation and must be able to demonstrate

such compliance upon request.

evia aa y

SCA focuses on its current environmental status and on future improvements to reduceits environmental impact. Suppliers should be able to demonstrate their commitment

and ability to support this initiative. A documented Environmental Management Sys-tem (EMS) must be implemented.

At a minimum, the EMS should include:n An Environmental and/or Sustainability Policyn A documented investigation of the suppliers current environmental impact,

including analyses and prioritisations. This to be used as a base for planning of

actions to reduce the impactn Compliance with all legal requirementsn Dened and documented responsibilities, and available resourcesn Setting of goals and actions for continual improvementn

Regular management review of the EMS and its effectiveness

The preferred level is a current ISO14001 certication.

ey a a

SCA hygiene business is working to reduce its greenhouse gas emissions from a holisticperspective, i.e. from the extraction of resources, through production, transportation,

use, and end of product life. SCA hygiene business expects all suppliers to actively workto reduce emissions, both in terms of energy for manufacturing, transportation, and the

source of material.Suppliers must have an energy efciency program that includes activities and goals

for improving energy efciency.

SCA hygiene business prefers that its suppliers increase the proportion of renewable1)

energy they use and work with alternative materials that are more environmentally

sound.SCA hygiene business promotes transport modes with low emissions per ton-kilo-

metre and optimizing of the freight and transport between supplier and SCA hygienebusiness.

4 Eviomet

1) According to EU-directive 2001/77/EC: wind, solar, geothermal, wave, tidal, hydropower, biomass, landfill gas,sewage treatment plant gas and biogases.


16/32

evia quiai

SCA hygiene business continually assesses the environmental performance of its sup-

pliers. As part of that, and as input for Life Cycle Assessments and/or environmentallabelling, updates and surveys might be necessary.Suppliers are expected to answer questions on such topics as:n use of energy (electricity and fuels)n raw material and nished materialn emissions to air, efuents to water and solid wasten bre raw materials and pulp production

SCA hygiene business prefers that suppliers also include environmental information

from their sub-suppliers.

If the supplier prefers, a condentiality agreement can be signed to restrict the use of

the information to a level where only the suppliers environmental status is assessed.

pu

Responsible use of wood raw material

SCA hygiene business requires its pulp suppliers to use timber that originates only fromknown sources. Timber from the following types of sources is not accepted:n Illegally logged timbern Timber from areas where human rights or the traditional rights of indigenous

peoples are being violatedn Timber from high conservation value forestsn Timber from protected areas, parks or similar, where harvesting operations are not

complementary to responsible forest managementn Timber originating from Genetically Modied Organisms (GMOs) containing liv-

ing genes or materials capable of reproductionn Timber from areas being transformed from natural forests into plantations

Pulp suppliers must have reliable systems and documented procedures in place which en-able adequate control of the supply chain and traceability of the origin of wood raw ma-

terials. This should ultimately be veried by independent certication (Chain of Custody).

SCA hygiene business expects its suppliers to ensure that the forests from which they aresupplying the wood bre are well managed and, ultimately, are independently certied.

The proportion of timber originating from certied forests should be continually re-viewed and suppliers are requested to show plans for their forest certication efforts.FSC, PEFC, SFI, and CSA2) are certication schemes recognised by SCA hygiene business.

aGE

4

4


17/32

Other certication schemes may be con-

sidered on a case-by-case basis.

Pulp production

The environmental impact of pulp pro-duction, i.e. emissions to air (greenhouse

gases (GHG), sulphur and nitrogen ox-ides) and efuents to water (chemical oxy-

gen demand (COD)/total organic carbon(TOC) and/or biological oxygen demand

(BOD), adsorbable organic halides (AOX)and phosphorus), contributes to the meas-

urement of suppliers environmental per-formance. Levels at the European IPPC(2008/1/EC)/BAT3) standard are preferred.

Fibre based materials

Suppliers of any bre based material (e.g.packaging, airlaid, tissue, certain mer-

chandise) to SCA hygiene business mightbe asked to full the same requirements as

those for pulp suppliers as regards virginbased bres. For recycled bres, the per-centage content and information about

post-consumer and pre-consumer contentmay be requested.

ouaia a a ay

All suppliers are required to provide in-formation requested to enable fullmentof SCA hygiene businesss obligations re-

garding occupational health and safety.Relevant safety information in the local

language of the receiver as well as in Eng-lish must always be available.

2) Forest Stewardship Council, Programme for the En-dorsement of Forest Certification Schemes, SustainableForestry Initiative, Canadian Standards Association.

3) Integrated Pollution Prevention and Control/Best Avail-able Technique


18/32

cia iai

All materials delivered must follow applicable chemical legislation.

Suppliers may be required to follow chemical legislation for other parts of the worldthan where the material is delivered as the nal SCA hygiene business product may be

distributed globally.

Examples of chemical legislation

n Regulation 1907/2006/EC called REACH (Registration, Evaluation, Authorisationand Restriction of Chemicals).

SCA hygiene business requires suppliers supplying within the EU to take fullresponsibility for pre-registering, registering, notifying and/or applying for authori-

sation as and when required. This also applies when customs documents identifySCA hygiene business as the importer

n Toxic Substances Control Act (USA)n NICNAS, National Industrial Chemicals Notication and Assessment Scheme (AU)n SEPA Order No 7 (China REACH)(China)n Chemical Substances Control Law (Japan)n Food contact legislationn Occupational health & safety (hazardous substances) legislation

cia ia SCA hygiene business has dened chemical substances which are of special concern and

are subject to specic restrictions. These chemicals are of special concern if intentionallyadded to materials supplied to SCA hygiene business, but also if delivered for use asprocess chemicals in our processes.

In the production processes there may exist such circumstances that make exceptionsfrom this list necessary.

See Annex A3 for chemicals of special concern.

5 Chemicls

aGE

6

5


19/32

SCAs Code of Conduct was established in 2004 and is a set of standards that continuallybuilds on our core values Respect, Excellence and Responsibility. As part of this com-

mitment, SCA is also a member of the United Nations Global Compact that consists of10 principles in the areas of human rights, labour standards, the environment and anti-

corruption. SCA also expects suppliers to adhere and act according to the same valuesas SCA. This section of the supplier standard sets forth the minimum Code of Conductrequirements that suppliers to SCA hygiene business must meet.

naia aw a uai

Suppliers must, as a minimum, comply with applicable international and national lawsand regulations. However, it is important to know that SCA hygiene business require-

ments may sometimes exceed the requirements set out in international and nationallaws.

ha a ay

A safe and healthy work environment shall be provided for all employees and the sup-

plier shall take effective steps to prevent potential accidents and injuries to workers. Aprocess for continual monitoring and improvement of the work environment shall be

in place and a management representative responsible for the health and safety of allpersonnel shall be appointed. In general, SCA hygiene business expects that its suppliers

will provide safe and humane working conditions for all their employees.

ey ai

n Non-discrimination

No discrimination is tolerated based on gender, marital or parental status, ethnic or

national origin, sexual orientation, religious belief, political afliation, age or dis-ability.

n Wages and benefits

Suppliers should pay fair wages and benets that at least meet the minimum legal

and/or industry standard (based on local customs and regulations).n Freedom of association and the right to collective bargaining

Suppliers should recognise the fundamental right of employees to decide on whether

to be represented by recognised unions of their choice, and should provide the rightfor employees and their trade unions to engage in collective bargaining. The practices

should be based upon internationally recognised labour standards and take into ac-count the customs and regulations of the country in which the supplier operates.

6 Code of Codct


20/32

Furthermore, this Supplier Code of Conduct would expect:n Employment contracts

All employees are expected to have an employment contract, whether they are short

term, long term or temporary.n Working hours

Suppliers should comply with applicable international and national laws and indus-

try standards on working hours.

bui ai

n Ethical behaviour

Suppliers are expected to conduct business in a transparent and ethical manner andshall not participate in any illegal, corrupt or improper business practices.

n Supplier engagement

SCA hygiene business expects its suppliers to conduct their operations with consid-eration for the standards and values expressed in this Code of Conduct down its

supply chain.

r ua i

Fundamental human rights should be respected, both in terms of suppliers own em-

ployees and in each suppliers sphere of inuence.n Child labour

The supplier shall not engage in or support the use of child labour as dened by

international and national laws.n Forced or compulsory labour

The supplier shall not engage in or support the use of forced or compulsory labouras dened by international and national laws. Suppliers shall not inict or threaten

to inict corporal punishment or any other forms of abuse.

cuiy ai

SCA hygiene business encourages its suppliers to be corporate citizens and have a posi-tive inuence in the communities they operate in.

cuiai a ivay aa

SCA hygiene business expects its suppliers to adhere to the condentiality of informa-tion exchange and to respect the privacy of data relating to individual persons.

giva/cai pu

SCA hygiene business expects its suppliers to have a grievance procedure in place where

employees can report violations without risk of discrimination.

evi

Suppliers must comply with relevant legislation and are expected to act in an environ-

mentally responsible manner. See chapter 4, Environment of the Supplier Standard fordetailed requirements.

aGE

8

6


21/32


22/32

This annex describes the requirements re-

garding contamination prevention in the sup-

pliers production processes and premises.

Wherever relevant, written instructions should

be available.

pa yi

. Personal hygiene is primarily the re-

sponsibility of the individual concerned

but should be enforced by management

where necessary, e.g. in cases in which

an employee continually ignores the

established procedures.

b. Appropriately clean clothing (includ-

ing clean shoes) must be worn by all

employees in all areas where materialsare exposed. This includes maintenance

operations.

c. Where appropriate, employees hair must

be tied back and covered.

d. Hand washing facilities should be avail-

able within a reasonable distance of

production and packing areas.

e. Eating and drinking must be prohibited ex-

cept in designated areas (with the possible

exception of drinking water in plastic bot-

tles). Suitable separate premises should

be provided where employees may eat.

f. The use of tobacco must be prohibited

except in designated areas. Such areas

must be well away from the production

environment.

g. Visible and/or detectable plasters or

dressings must cover cuts or sores on

exposed skin.

h. Where appropriate, hygiene regulations

should be clearly displayed.

pi a qui

. Premises and equipment must be

cleaned in accordance with written clean-

ing instructions. Records should be kept.

j. Lighting that is sufficiently intense to allow

the detection of defects is required in

production, inspection and storage areas.

k. Unless the supplier has equivalentexpertise and resources, a reputable

pest control contractor should be con-

sulted. Written reports are to be provided

after each inspection of the pest control

system. Appropriate measures should

be taken to prevent insects, birds and

rodents from entering the premises, e.g.

by implementing fly-screening and door-

closing routines.

l. All sources of glass and brittle plastic in

or above the production process must

be identified. Appropriate steps must be

taken to prevent fragments from contami-

nating materials or products after a break-

age, e.g. by enclosing lights or replacing

glass windows. Appropriate procedures

must be followed in the event of a break-

age.

x 1

Hygiee cotol

aGE

20

1


23/32

m. Solvents and cleaning agents must be

stored in appropriate designated areas.

Leaks of oils and lubricants should be

prevented by means of an adequate

maintenance system.

Process additives such as oils, greases,lubricants and cleaning agents should

not be allowed to come into contact with

materials or products.

Contamination from dripping water, con-

densation, etc., should be prevented.

n. Needles, razor blades and similar items

are to be kept in designated areas and

away from production processes. Used

blades, etc., are to be collected in desig-

nated boxes.

o. During production, all tools and unused

spare parts must be kept away from ma-

chinery.

p. All materials and semi-finished products

at all stages of the production process

must be stored in such a way as to pre-

vent their contamination.

Pallets should be in good condition and

should be kept clean and dry.

If wooden pallets are used, measures

should be taken to prevent contamina-

tion of the material (e.g. wood splinters).

Where appropriate, clean layer sheets

should be used.

Q. All repairs and maintenance carried out

during production must be suitably moni-

tored to prevent contamination.


24/32

ui

A process flow diagram should be prepared.

It should be sufficiently detailed and should

cover all steps from receipt of raw materials

to loading of finished goods.

Each process step should be assessed onthe basis of the above factors and document-

ed as described below.

ri iiai iiiai

For each contamination risk identified by the

team, the first priority should be to eliminate

the risk definitively. This is mainly a question

of identifying technical solutions.

Where no realistic definitive solution is

identified, a daily prevention or detection

system should be defined.Daily prevention should be described in

written procedures and work instructions.

The procedures and instructions must be

integrated in the suppliers quality manage-

ment system and, where appropriate, records

of daily preventive measures must be kept.

duai

The contamination risk analysis should be

documented and the documentation should

include the following as a minimum:

n Team members

n List of potential risks

n Process flow diagram

n Lists of identified contamination risks at

each step in the process

n Solutions identified

a) Definitive elimination of the risk

b) Daily prevention routine

c) Detection system

A risk analysis shall be conducted each time

an important change is introduced in the pro-

duction process. In all cases, SCA hygiene

business recommends that a risk analysis

should be performed at least once every two

years.Before a contamination risk analysis

begins, a dedicated team should be assigned

to the task. Departments in daily contact with

the production process should be involved.

The size of the team should be in proportion

to the size and complexity of the production

process. A minimum of three members is

recommended.

iyi ia i a

The first step is to create a list of agents thatmay pose a risk of contamination of the ma-

terial. This should be completed before the

production process itself can be assessed.

The following minimum risks should be

included:

n Glass and brittle plastic

n Liquids used in the process

n Metals

n Wood splinters

n Tools and spare parts

n Dust and dirt

n Contamination by premises,

e.g. walls, floors, etc.

n Contamination by animals,

e.g. insects, rodents, etc.

n Contamination by humans,

e.g. jewellery, food, etc.

x 2

Hzd lysis dcotmitio pevetio

aGE

22

2


25/32

fwa

The following flowchart

illustrates the principlesand main steps in hazard

analysis and contamina-

tion prevention:

strt

end

Identification of risk factors

Preparation of process flow diagram

Assessment of production steps

Documentation

Is there a risk?

Final step?

Can be definitivelyeliminated?

YES

YESNO

YES

NO

NO

Definitive solution

Prevention ordetection

Integration inquality system


26/32

x 3

Chemicls ofspecil coce

cia i ta 1 may not be intentionally added to materials supplied to SCA hygiene

business. Exceptions from the list may exist for materials delivered to SCA hygiene business

only to be used as process chemicals.

cia i ta 2 are of special concern and their presence as a result of intentional or

non-intentional addition will always be assessed in each individual case. Note that this list isnot exhaustive.

aGE

24

3


27/32

ta 1.Chemical substance

ay sbstce clssified s Cciogeic, Mtgeic o toxic to repodctio (CMr sbstces cls-

sified with r45, r46, r49, r60, r61), ctegoy I o II de cet Eu legisltio d listed i aex I of

iective 67/548 o

CMr sbstces i Ctegoy 1a d 1B with Hzd sttemets: H340, H350 d H360 ccodig

to he uited ntios Globlly Hmoised System of Clssifictio d Lbellig of Chemicls

(un-GHS), d Clssifictio, Lbellig d Pckgig of sbstces d mixtes, regltio (EC)

no 1272/2008 (CLP).

all sbstces i aex XIV of Eu rEaCH egltio 1907/2006

alleges clssified with r43 (fo fgce compoets, d pesevtives see ble 2)

Ceti metls d thei compods (cdmim, led, mecy, seic, chomim d ickel),

exemptios my be mde fo chomim (3+) i ceti pplictios

Phthltes (fo EP i cosmetic fomltios see ble 2)

Polyomtic hydocbos (PaH)

Ogoti compods

alkylpheols d thei ethoxyltes

Bispheol a (BPa)

Pefloooctoic cid (PFOa)

Pefloooctyl slphoic cid d its slts (PFOS)

Sbstces idetified s PB/vPvB sbstces, ccodig to Eu rEaCH regltio no. 1907/2006

ta 2. (n-xauiv)Chemical substance

Cciogeic, Mtgeic o toxic to repodctio (CMr sbstces, clssified with r40, r68, r62,

r63), ctegoy III de cet Eu legisltio d listed i aex I of iective 67/548 o

CMr sbstces i Ctegoy 2 with Hzd sttemets: H341, H351 d H361 ccodig tohe uited

ntios Globlly Hmoised System of Clssifictio d Lbellig of Chemicls (un-GHS), d Cls-

sifictio, Lbellig d Pckgig of sbstces d mixtes, regltio (EC) no 1272/2008 (CLP),

o de eview by officil egltoy bodies, e.g. IarC.

recogised o docmeted lleges (e.g fgces, pesevtives etc)

recogised o docmeted homoe distbig sbstces (edocie disptos)

all othe sbstces i the rEaCH cdidte list of Eu rEaCH egltio 1907/2006

Chemicl sbstces o the Clifoi Popositio 65 list

Ogometllic compods

Metls d iogic compods (e.g silve, coppe, coblt, timoy compods)

iethylphthlte i cosmetic fomltios

Hlogeted compods (ogic d iogic)

Pimy omtic mies

Ogophosphtes

Opticl bightees i celllose

Colots

ntl bbe


28/32

aGE

26

4


29/32

x 4

Legisltio dabbevitios

ISO:n ISO 9001 Quality management systems

Requirements

n ISO 10993 Biological evaluation ofmedical devices

n ISO 14001 Environmental managementsystems Requirementshttp://www.iso.org/iso/iso_catalogue.htm

Europe:n 76/768/EEC: Directive on cosmetic

products

n 88/378/EEC: Directive on the safety oftoys

n 93/42/EEC: Directive concerning medical

devicesn 1223/2009/EC: Regulation on cosmetic

products (replacing 76/768/EEC from July2013)

n 1907/2006/EC: Regulation concerningthe Registration, Evaluation,Authorisation and Restriction of Chemi-cals (REACH) http://echa.europa.eu/

n 1935/2004/EC: Regulation on materialsand articles intended to come into contactwith food

n 2001/95/EC: Directive on general product

safety

n 2002/95/EC: Directive on the restriction ofthe use of certain hazardous substancesin electrical and electronic equipment(RoHS)

n 2002/96/EC: Directive on waste electricaland electronic equipment (WEEE)

n 2006/66/EC: Directive on batteries andaccumulators and waste batteries andaccumulators

n 2008/1/EC: Directive on integratedpollution prevention and control

n 2009/48/EC: Directive on the safetyof toys (replacing 88/378/EEC fromJuly 2011)

For information regarding

European legislation:

http://eur-lex.europa.eu/RECH menu.

do?ihmlang=en

n BfR Recommendations on Food ContactMaterialshttp://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsp

n BfR Guidelines for the evaluation ofPersonal Sanitary Productshttp://bfr.zadi.de/kse/faces/resources/

INTENGLISCH.pdf

USA:n Consumer Product Safety Act

http://www.cpsc.gov/businfo/cpsa.html

n FDA 21 CFR: Food and drug administra-tion, code of federal regulations title 21http://www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfcfr/cfrsearch.cfm

n Federal Food, Drug and Cosmetic Acthttp://www.fda.gov/regulatoryinformation/leg-

islation/federalfooddrugandcosmeticactfdcact/

default.htm

n Medical Device Safety Act

n Toxic Substances Control Acthttp://www.epa.gov/agriculture/lsca.html

n California Proposition 65 Safe DrinkingWater and Toxic Enforcement Acthttp://oehha.ca.gov/prop65/background/

p65plain.html

liai a aa
http://eur-lex.europa.eu/RECH_menu.do?ihmlang=enhttp://eur-lex.europa.eu/RECH_menu.do?ihmlang=enhttp://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsphttp://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsphttp://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsphttp://bfr.zadi.de/kse/faces/resources/INTENGLISCH.pdfhttp://bfr.zadi.de/kse/faces/resources/INTENGLISCH.pdfhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmhttp://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htmhttp://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htmhttp://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htmhttp://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htmhttp://oehha.ca.gov/prop65/background/p65plain.htmlhttp://oehha.ca.gov/prop65/background/p65plain.htmlhttp://oehha.ca.gov/prop65/background/p65plain.htmlhttp://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfmhttp://bfr.zadi.de/kse/faces/resources/INTENGLISCH.pdfhttp://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsphttp://bfr.zadi.de/kse/faces/DBEmpfehlung_en.jsphttp://eur-lex.europa.eu/RECH_menu.do?ihmlang=en


30/32

Australia/New Zealand:n TGO AS/NZS 2869-2008 Therapeutic

Goods Order Standard for Tamponshttp://www.comlaw.gov.au/ComLaw/Legisla-

tion/LegislativeInstrument1.nsf/0/52FDF7F319

1FAE71CA25756D000E3DF3/$file/Explan

StateTGO82Final12209.pdf andhttp://www.standards.org.au/Default.aspx

n AS/NZS ISO 8124 Standard on safetyof toyshttp://www.standards.org.au/Default.aspx

n NICNAShttp://www.nicnas.gov.au/Chemicals_In_Australia.asp

n Australian Consumer Law (ACL)http://www.consumerlaw.gov.au/content/

Content.aspx?doc=home.htm

China:n SEPA order no 7 of the Measures on

Environmental Administration of NewChemical Substances, China REACH

viai

oX Adsorbable Organic Halides

s Australian Standard

bt Best Available Technology

br Bundesinstitut for Risikobevertung

(Federal Institute for Risk

Assessment, Germany)

bod Biological Oxygen Demand

cs Chemical Abstracts Service

cod Chemical Oxygen Demand

c/p Process capability calculations

cs Canadian Standards Association

ems Environmental Management

System

e the European Union

fsc Forest Stewardship Council

ghg Green House Gases

gmo Genetically Modified Organisms

gmp Good Manufacturing Practice

so International Organisation for

Standardisation

ppc/bt Integrated Pollution Prevention

and Control/Best Available

Technology

ncns National Industrial Chemicals Noti-

fication and Assessment Scheme

nZs New Zealand Standard

pefc Programme for the Endorsement

of Forest Certification Schemes

rech Registration, Evaluation,

Authorisation and Restriction

of Chemicals

sds Safety Data Sheet

sep State Environmental Protection

Administration (China)

spc Statistical Process Control

tgo Therapeutic Goods Order

toc Total Organic Carbon

tsc Toxic Substances Control Act (USA)

s United States of America

aGE

28

4
http://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/52FDF7F3191FAE71CA25756D000E3DF3/$file/ExplanStateTGO82Final12209.pdfhttp://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/52FDF7F3191FAE71CA25756D000E3DF3/$file/ExplanStateTGO82Final12209.pdfhttp://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/52FDF7F3191FAE71CA25756D000E3DF3/$file/ExplanStateTGO82Final12209.pdfhttp://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/52FDF7F3191FAE71CA25756D000E3DF3/$file/ExplanStateTGO82Final12209.pdfhttp://www.nicnas.gov.au/Chemicals_In_Australia.asphttp://www.nicnas.gov.au/Chemicals_In_Australia.asphttp://www.nicnas.gov.au/Chemicals_In_Australia.asphttp://www.consumerlaw.gov.au/content/Content.aspx?doc=home.htmhttp://www.consumerlaw.gov.au/content/Content.aspx?doc=home.htmhttp://www.consumerlaw.gov.au/content/Content.aspx?doc=home.htmhttp://www.nicnas.gov.au/Chemicals_In_Australia.asphttp://www.nicnas.gov.au/Chemicals_In_Australia.asphttp://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/52FDF7F3191FAE71CA25756D000E3DF3/$file/ExplanStateTGO82Final12209.pdfhttp://www.comlaw.gov.au/ComLaw/Legislation/LegislativeInstrument1.nsf/0/52FDF7F3191FAE71CA25756D000E3DF3/$file/ExplanStateTGO82Final12209.pdfhttp://www.consumerlaw.gov.au/content/Content.aspx?doc=home.htm


31/32


32/32

Global Supplier Standards for SCA hygiene business English

Documents

Transcript of Global Supplier Standards for SCA hygiene business English