BD Supplier Materials of Concern Guidance

BD Supplier Materials of Concern

Guidance

BD and BD Logo are trademarks of Becton, Dickinson and Company. © (2015) BD

This document contains guidance on how to access and complete the BD questionnaires as well as

providing details of BD’s sustainability strategy and information on regulations and requirements.

Version 6 July 28th

, 2015

BD Supply Base Compliance

E-mail: [email protected] http://www.bd.com/sustainability/

mailto:[email protected]

BD Supplier MOC Guidance BD and BD Logo are trademarks of Becton, Dickinson and Company. © (year) BD

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I. Material Disclosure Tool – Guidance for Suppliers

Evolving global environmental regulations and increasing customer demands have made understanding

the composition of all materials and products a top priority for BD. For this reason we are gathering data

on substances that have or are suspected to have negative impact on human health and/or the environment

and can pose risk under particular conditions. To learn more about BD Sustainability policy, please

review our Sustainability Report by clicking on the following link: BD Sustainability Report.

Material Disclosure is a web application that is used for data collection. It is also a communication tool

between BD and its suppliers. Communication with suppliers is initiated by The BD Supply Base

Compliance Team sending an e-mail with a link to the Material Disclosure Supplier Portal. The supplier

will use the link to access the BD questionnaire. Further communication between BD and suppliers can

be conducted using the following e-mail address: [email protected].

https://www.bd.com/sustainability2014/



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Contents:

I. Material Disclosure Tool – Guidance for Suppliers ........................................................................ 2 Receiving the E-mail ............................................................................................................................. 4 First Time Log-in .................................................................................................................................. 4

Adding a Responder .............................................................................................................................. 7 Reset password ...................................................................................................................................... 9

Subsequent Logins .................................................................................................................................. 10 Entering the Questionnaire...................................................................................................................... 12 Completing the Questionnaire ................................................................................................................ 13 MOC Questionnaire ................................................................................................................................ 14

Copying (Importing/Exporting) Responses ............................................................................................ 17 Export the answers from one questionnaire to another. ...................................................................... 17

Importing the answers from one questionnaire to another .................................................................. 18 Questionnaire Options............................................................................................................................. 19 Subsequent Questionnaires ..................................................................................................................... 21

II. Definitions .......................................................................................................................................... 22 Material Nature ....................................................................................................................................... 22

Substance ............................................................................................................................................ 22 Mixture ................................................................................................................................................ 22

Article.................................................................................................................................................. 22 Article with intended release ............................................................................................................... 22 Packaging material -............................................................................................................................ 22

FMD – Full Material Disclosure ............................................................................................................. 22 Intentionally added substance ................................................................................................................. 22

Concentration threshold .......................................................................................................................... 23 SVHC – Substances of Very High Concern ........................................................................................... 23 OEM – Original Equipment Manufacturer ............................................................................................. 23

CAS#, CAS-No. - Chemical Abstract Service index number ................................................................. 24 EINECS - European Inventory of Existing Commercial chemical Substances ...................................... 24 Regulations.............................................................................................................................................. 24

III. FAQ – Frequently Asked Questions ................................................................................................ 26


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Login to the Portal for the First Time

Receiving the E-mail

As a BD supplier you shall receive an e-mail from

[email protected] that will contain:

A link to the Material Disclosure Supplier Portal,

A list of pending product questionnaires.

First Time Log-in

Step 1: Within the e-mail message you will see a list of Pending

Product Questionnaires by their Product Name, Product Number

and Supplier Name (your company or its subsidiaries). To enter

the supplier portal click on ‘click here’ contained in the e-mail

message.

Step 2: You will be asked to verify your email address

and set a password. Please type a Password and confirm

it. Click ‘Set Password & Validate’ button.

NOTE: All fields in red are mandatory to fill in.



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Step 3: You will be directed to the Material

Disclosure login page where you will be asked

to enter your email address and newly set password.

Click ‘Sign In’ button.

Step 4: Since this is the first

login, you will be asked to verify

your company information by

providing details such as:

Company Name, Address, etc.

Once you have it completed,

click ‘Save & Verify’ button


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Step 5: You will then be asked to verify

your contact info by filling in fields as

shown on the screen below. Please

make sure that all headers marked in a

red color are completed as these are

mandatory fields. You will be also

asked to choose or confirm a role for a

contact.

NOTE: If you are not the correct point

of contact within your organization or

if you want to add another contact,

please provide appropriate contact

details by clicking ‘Add a responder’

(see next section to check how to

complete this).

In order to reset your password - click

‘Reset pwd’ (see next section to check

how to complete this) button and a link

will be sent to your email address. It

expires within 2 hours.

Once you have completed all of the

information, click the ‘Save & Verify’

button.


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Step 6: If you are the contact person for multiple accounts (Company Names), choose ‘Becton

Dickinson’, then click ‘Select’ and you will be able to access all questionnaires assigned to you.

Adding a Responder

If you are not the correct point of contact, please provide contact details of the person/group within your

organization who should receive the questionnaire.

Step 1: Click ‘Add a Responder’ button.

Step 2: You will see all of the contact email addresses assigned to your company. To add a new contact,

click the ‘Add’ button.


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Step 3: Provide first and last name, email

address and the role of the new contact - these

fields are mandatory.

You can also provide information such as:

address, phone, country etc.

Step 1.4: Once you have completed the required

information, click ‘Save’.


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Step 1.5: By selecting newly added contact and clicking on the ‘Notify’ button the campaign

questionnaire will be forwarded to the new contact person and he or she will be able to log into portal.

Reset password

Step 1: Once you click ‘Reset pwd’ you will receive an e-mail with link to reset the password from

[email protected]. Open the e-mail and click ‘Reset my password’.


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Step 2: You will be directed to webpage where you can set up a new password. Once fields ‘New

Password’ and ‘Confirm’ completed click ‘Change Password’ button.

Subsequent Logins

Step 1: By clicking the link found in the email it will

take you to the Material Disclosure Supplier Portal.

You will be asked to verify your email and set a

password.

If you remember the previously set password click ‘I

know my password. Take me to the login page’ button.

If you have forgotten your password you can reset it

by providing new one and confirming it.


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Step 2: You will be taken to the login page. Insert your email address, password and click ‘Sign In’

Step 3: Once you are signed in to the Supplier Portal you will see a list of pending questionnaires. The

color of the flag on the left reflects your questionnaire status:

The questionnaire for this Campaign is currently in process and has not yet been completed and

submitted.

The questionnaire for this Campaign has been completed and submitted.

The questionnaire for this Campaign has not been completed or submitted.


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Entering the Questionnaire

Choose the questionnaire you would like to open and double click on it. Once you have opened the

relevant questionnaire you will see the product name, product number and supplier name on the top left

hand side of the window (in the screen shot below: ‘Test Item 2’ is the product name, ‘Test 2’ is product

number and ‘Test Supplier’ is supplier name).

NOTE: If BD does not have the supplier product number on file the BD product number will be

displayed.

NOTE: BD is committed to compliance with variety of regulations. As our valued supplier you may be

requested to provide several information (MOC, Conflict Minerals, RoHS etc.). Please choose the correct

questionnaire by selecting the Questionnaire Name. You are able to sort by the date in column:

‘Requested on’ to see the latest request. If you supply multiple items to BD you may have to change the

page or scroll down to access incomplete questionnaires.


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Completing the Questionnaire

Please review the questionnaire, read the instructions and answer the questions. If you have any queries

please refer to this Guidance document or contact us at: [email protected] for further assistance.

Important Points to Remember:

All questions in red are mandatory and it is not possible to submit the questionnaire unless

these questions are completed.

When a substance is listed on more than one Regulatory List and you declare its presence in your

product in one question, the substance will be automatically copied to the other relevant

regulatory questions within the questionnaire. For example if you add Cadmium in the REACH

SVHC section, it will also automatically appear in the RoHS section as Cadmium is regulated

under the REACH and RoHS regulation.

If a substance that you would like to add is not listed, please contact us at [email protected].

Be aware that some questions are triggered by answers provided in the previous question.

Questionnaires submitted are visible in the Supplier Portal (as PDFs) for 60 days since the

submission. You are able to download a copy for internal use.




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MOC Questionnaire

BD is committed to reducing our environmental impacts and supporting our customers and suppliers to

do the same. Evolving global environmental regulations and increasing customer demands have made

understanding the full composition of all materials and products a top priority for BD. The Materials of

Concern questionnaire is divided into several sections such as Full Material Disclosure, SVHC,

California Proposition 65 etc.

BD's preferred approach is for suppliers to provide full material disclosure (FMD). This ensures that the

data collection effort is very efficient in the long term as only changes to the supplied material need to

be communicated to BD.

If you are not able to provide FMD you are requested to provide response to the BD Materials of Concern

section. This section contains questions referring to different regulations, as follows:

1. Does your product contain any substances listed on the latest EU REACH Regulation “Substances

of Very High Concern” Candidate List in concentration above 0.1% w/w?

2. Does your product contain any substances listed under the California Safe Drinking Water and

Toxic Enforcement Act of 1986 (California Proposition 65) by the State of California?

3. Does your product contain any chemicals listed in EU Restriction of Hazardous Substances in

Electrical and Electronic Equipment Directive 2011/65/EU (RoHS2) in concentration above 100

PPM for cadmium and 1000 PPM for remaining substances?

4. Does your product contain any substances listed on Annex XVII of the EU REACH regulation?

5. If your product is a packaging material, does it contain any substances regulated by the Toxics in

Packaging Clearinghouse (TPCH) of the Coalition of Northeastern Governors (CONEG) in the

USA and by EU Packaging and Packaging Waste Directive 94/62/EC in concentration above


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100 PPM? Does it contain polystyrene in concentration equal to or above 100 PPM or less than

100 PPM but intentionally added?

6. Does your product contain any phthalates in concentration equal to or above 100 PPM or less than

100 PPM but intentionally added?

7. Does your product contain any other BD Materials of Concern listed below in concentration equal

to or above 100 PPM or less than 100 PPM but intentionally added?

Name CAS EINECS Threshold

Antimony trioxide 1309-64-4 215-175-0 100 PPM

Arsenic (& compounds) 7440-38-2 231-148-6 100 PPM

Beryllium 7440-41-7 231-150-7 100 PPM

Bisphenol A (BPA) 80-05-7 201-245-8 100 PPM

Butylparaben 94-26-8 202-318-7 100 PPM

Dimethyl fumarate 624-49-7 210-849-0 100 PPM

Ethylparaben 120-47-8 204-399-4 100 PPM

Formaldehyde 50-00-0 200-001-8 100 PPM

Isononylphenol 11066-49-2 234-284-4 100 PPM

Methylparaben 99-76-3 202-785-7 100 PPM

Nonylphenol 25154-52-3 246-672-0 100 PPM

Perfluorooctanoic acid (PFOA) 335-67-1 206-397-9 100 PPM

Phenol, 4-nonyl-, branched 84852-15-3 284-325-5 100 PPM

Polyvinyl Chloride (PVC) 9002-86-2

100 PPM

Propylparaben 94-13-3 202-307-7 100 PPM

Tributyltin Oxide (TBTO) 56-35-9 200-268-0 100 PPM

Triclosan 3380-34-5 222-182-2 100 PPM

8. Does your product contain any substances listed in Table 3.1 of Annex VI of the EU

Classification Labelling and Packaging (CLP) Regulation classified as carcinogenic, mutagenic or

toxic for reproduction (CMR) of category 1a or 1b in concentration equal or above 100 PPM?


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9. Does your product contain latex?

10. Does your product contain any substances of animal origin?

NOTE! The links to the regulations or lists of regulated substances may be found in Section Definitions of this

Guidance document.


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Copying (Importing/Exporting) Responses

A questionnaire will be sent for each product you (or your company subsidiaries) supply to BD. It is

possible to copy your answers from a completed questionnaire to the other questionnaires. There are two

ways of doing this: importing answers from another submitted questionnaire and exporting to

questionnaires not submitted yet. To perform one of above click on the button ‘Import/Export’ available

at the top of each questionnaire. Data can be exported for a maximum 100 products at once.

NOTE: If you choose to Export responses from current Questionnaire X to Questionnaire Y remember

that by submitting Questionnaire X, Questionnaire Y will be submitted automatically with the same

responses. If you choose to Import responses from Questionnaire X to Questionnaire Y you will be able

to edit answers before submission.

Export the answers from one questionnaire to another.

Upon clicking Import/Export button choose the questionnaires to which all of your answers should be

copied (right side of the window, where it says: ‘Export to’).


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Click ‘Save’ button and you will be directed back to the questionnaire. Remember that submitting the

questionnaire causes automatic submission of all of the questionnaires that you exported responses to.

You will see the status change to ‘Questionnaire complete’ (green flag) not only for the item you

answered but also for the one to which you exported your answers.

NOTE: You should only use this option if the responses to every question are identical. You cannot

change any of the ‘copied’ questionnaires prior to submitting it.

Once the action is completed you will see window as below:

Importing the answers from one questionnaire to another

In order to import answers from a questionnaire choose the questionnaire from which you would like to

copy the answers (left side of the window, where it says: ‘Import from’). Then click ‘Save’, you will be

directed back to the questionnaire and will see the answers in the current questionnaire. You can now

verify and edit them if needed.


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Questionnaire Options

At the bottom of the questionnaire window there are five (5) buttons:

Option 1:

By clicking it you refresh the questionnaire.

Option 2:

By clicking it you are saving provided answers. Next time you enter the questionnaire you will be able to

view your answers and edit them.


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If you click the ‘Save’ button, the flag status of the questionnaire changes from red color: ‘No response

yet for campaign questionnaire’ to yellow color: ‘Campaign questionnaire in process, not completed

yet’.

NOTE: ‘Save’ button does not submit your questionnaire to BD. It just gives you the opportunity to save

the answers you previously provided in order to have them visible when entering the portal again.

Option 3:

By clicking it you submit your response to the questionnaire to Becton Dickinson, at that point you will

no longer be able to edit this questionnaire.

NOTE: When you log in to the Supplier Portal subsequently you will see the submitted questionnaire(s)

with the most current answers in PDF format. You can view the questionnaire(s) up to 60 days after

submission. At that point the document(s) will be removed from the portal.

Option 4:

By clicking it you are able to review and download the PDF version of questionnaire.

Option 5:

By clicking it you are able to provide another contact person who should be responsible for completing

the questionnaire. (Described in section Adding new responder)


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Subsequent Questionnaires

New questionnaires will be sent to you by email as regulatory and BD requirements are updated.

Once you have logged into the Supplier Portal, you will see the list of the questionnaires we have sent to

you in the last 60 days.

Please note that new questionnaires will be pre-populated with answers you provided in previously

submitted questionnaires. You are able to update these responses and before submitting the questionnaire

to Becton Dickinson.

NOTE: Please remember to provide current date before submitting the questionnaire to Becton

Dickinson.


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II. Definitions

Material Nature

Substance - a chemical element and its compounds in the natural state or obtained by any manufacturing

process, including any additive necessary to preserve stability and any impurity deriving from the process

used, but excluding any solvent which may be separated without affecting the stability of the substance or

changing its composition.

Mixture - a preparation or solution composed of two or more substances.

Article - object which during production is given a special shape, surface or design which determines its

function to a greater degree than its chemical composition.

Article with intended release - object that release substances during their use, and this release is

intended as part of the main function of the article or to provide a desired other effect.

Packaging material - Material used to enclose or protect products for distribution, storage, sale, and use.

E.g box, bag, carton, top/bottom web, corrugated container, shrink film. Under the REACH regulation

packaging is considered an article and as such should be assessed independently of the object it contains.

FMD – Full Material Disclosure

Full Material Disclosure is a full and complete % breakdown of the material composition to the lowest

substance level (CAS) including all additives. Substances in polymers which cannot be mechanically

disjointed must still be reported (e.g. phthalates in PVC). Additives used in a polymerisation process but

do not end up in the polymer must also be reported.

Intentionally added substance - substance added to a product in any amount to achieve specified

properties.


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Concentration threshold - substance concentration below which the presence

of the substance is considered insignificant for specific reasons, unless the substance is intentionally

added in order to achieve particular properties of the product.

SVHC – Substances of Very High Concern

Some substances have hazards that have serious consequences, e.g. they cause cancer (carcinogenic), or

they have other harmful properties and remain in the environment for a long time (persistent) and

gradually build up in animals (bioaccumulative) and these are substances of very high concern. This

category also includes substances demonstrated to be of equivalent concern, such as “endocrine

disruptors”. One of the aims of REACH is to control the use of such substances via authorisation and

encourage industry to substitute these substances for safer ones. Under the REACH Regulation, the

European Chemical Agency (ECHA) have created the REACH Candidate List of Substances of Very

High Concern (SVHC). This list is updated on a regular basis (every 6 months).

OEM – Original Equipment Manufacturer

OEM is a term used when one company makes a part or subsystem that is used in another company's end

product. As an OEM supplier for BD you are requested to report separately for product manufactured for

BD and the packaging. You can either provide Full Material Disclosure (FMD) for the product and the

packaging or respond to regulatory questions in BD MOC sections.


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CAS#, CAS-No. - Chemical Abstract Service index number

Unique numeric identifier, designates only one substance, has no chemical significance, is a link to a

wealth of information about a specific chemical substance.

EINECS - European Inventory of Existing Commercial chemical Substances

It is a list of all chemical substances that were on the European Community market between 1 January

1971 and 18 September 1981.

Regulations

Below are links to regulations we ask about in BD MOC Questionnaire.

Regulation Link

EU REACH www.ec.europa.eu/environment/chemicals/reach/legislation_en.htm

EU REACH - SVHC www.echa.europa.eu/web/guest/candidate-list-table

EU Restriction of Hazardous

Substances in Electrical and

Electronic Equipment

Directive 2011/65/EU (RoHS2)

http://ec.europa.eu/environment/waste/rohs_eee/legis_en.htm

Coalition of Northeastern

Governors (CONEG) http://www.coneg.org/

California Proposition 65 www.oehha.ca.gov/prop65/prop65_list/Newlist.html

Packaging and Packaging

Waste www.ec.europa.eu/environment/waste/packaging_index.htm

http://www.ec.europa.eu/environment/chemicals/reach/legislation_en.htm

http://www.echa.europa.eu/web/guest/candidate-list-table

http://ec.europa.eu/environment/waste/rohs_eee/legis_en.htm

http://www.coneg.org/

http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html

http://www.ec.europa.eu/environment/waste/packaging_index.htm


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Table 3.1 of Annex VI of the

EU Classification Labelling

and Packaging (CLP)

http://eur-lex.europa.eu/legal-

content/EN/TXT/PDF/?uri=CELEX:32008R1272&from=en

Annex XVII to EU REACH

regulation

http://echa.europa.eu/addressing-chemicals-of-

concern/restrictions/list-of-restrictions

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R1272&from=en

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R1272&from=en

http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions

http://echa.europa.eu/addressing-chemicals-of-concern/restrictions/list-of-restrictions


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III. FAQ – Frequently Asked Questions

Q1: What happens if I do not respond to the questionnaire? ...................................................................... 26 Q2: I am not the correct person to be contacted for environmental compliance issues. How can I indicate

the correct contact in my company? ........................................................................................................... 27

Q3: Why am I being asked about regulations which I am not legally obliged to comply with? (E.g. I am

not supplying to EU and I am asked about SVHCs from the EU REACH Regulation). ............................ 27 Q4: I have already answered a questionnaire. Why am I being asked again? ............................................ 28

Q5: What happens if I do not respond on time? ......................................................................................... 28 Q6: I am unable to login to the MD Supplier Portal. I receive a pop-up message as shown below.

What should I do? ....................................................................................................................................... 29

Q7: I have multiple items to submit and all answers for them are the same. How can I copy my answers

from one questionnaire to another? ............................................................................................................. 29 Q8: I do not see all materials I supply to BD listed in the Supplier Portal. I also see products which are

not supplied by my company. What should I do? ....................................................................................... 30 Q9: I do not see the ‘Submit to Becton Dickinson’ button at the bottom of the questionnaire.

What should I do? ....................................................................................................................................... 30 Q10: When I enter the Portal I receive pop-up message as shown below. What shall I do? ...................... 30 Q11: Why should I answer question about product weight? ...................................................................... 31

Q1: What happens if I do not respond to the questionnaire?

A: Lack of response within the given time will result in escalation to BD Global Procurement and

if a satisfactory response is not provided, BD may be forced to seek an alternative supplier. Please

contact the BD SBC Team ([email protected]) to discuss or obtain further guidance.



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Q2: I am not the correct person to be contacted for environmental compliance issues. How

can I indicate the correct contact in my company?

A: There are several ways to indicate if another person should be contacted or forward the e-mail/

questionnaire to this person:

1. When you receive the first email with the link to the portal and are asked to verify your company

details. Click ‘Add a responder’ so that a new contact will be created for your company and the

questionnaire forwarded. The whole process of adding a responder is described in Add a

responder Section in this document.

2. When you enter a questionnaire for a certain product - on the bottom of the window you will see a

button ‘Add a responder’.

3. When you receive emails with requests to complete the questionnaire you may respond to this

message and provide BD with correct person details.

NOTE: Do not forward the email to another person as the link is personalized and linked with

your e-mail.

Q3: Why am I being asked about regulations which I am not legally obliged to comply with?

(E.g. I am not supplying to EU and I am asked about SVHCs from the EU REACH Regulation).

A: BD is a global organization and as such sells and ships its product to various countries around the

world. Therefore even if you do not directly ship your products to BD Europe they may be incorporated

into BD’s products which are sold or shipped to other regions such as Europe. BD needs to comply with


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these regulations and is therefore reliant on information provided by its suppliers to meet these

obligations.

Q4: I have already answered a questionnaire. Why am I being asked again?

A: Adherence to most recent environmental and health regulations as well as the ability to provide our

customers with up to date information relating to our products is a top priority for BD. To achieve this,

BD tracks changes to regulations and as a result updates the BD MOC list. Updated questionnaires are

then sent to our suppliers. Please note that the questionnaire will be pre-populated with your previous

responses. You are able to update these prior to submitting the completed questionnaire to BD, remember

to always change date to current one.

NOTE: If Full Material Disclosure is provided this will limit the number of times we contact you

regarding the composition of your products.

Q5: What happens if I do not respond on time?

A: If you are not able to provide a response within the specified timeline, please immediately contact the

BD MOC team using the email address: [email protected].

NOTE: If you are not willing to provide BD with the necessary data within the requested timeframe, this

may result in BD seeking alternative suppliers.



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Q6: I am unable to login to the MD Supplier Portal. I receive a pop-up message as shown

below. What should I do?

A: To login to the Supplier Portal use the link:

http://www.actiocms.com/outreach/.

Type in your e–mail address and password. If

you do not remember the password click

‘Forgot pwd?’ and reset the password.

Q7: I have multiple items to submit and all answers for them are the same. How can I copy

my answers from one questionnaire to another?

A: You can easily copy your answers using button ‘Import/Export’ available at the top of each

questionnaire. The instructions on how to do this are described in detail within Section Copying

(Importing/Exporting) Responses in this document.

http://www.actiocms.com/outreach/


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Q8: I do not see all materials I supply to BD listed in the MD Supplier Portal. I also see

products which are not supplied by my company. What should I do?

A: If you notice any discrepancies in the MD Supplier Portal please immediately communicate this to the

BD SBC Team by sending e-mail to: [email protected].

Q9: I do not see the ‘Submit to Becton Dickinson’ button at the bottom of the questionnaire.

What should I do?

A: In order to see buttons available at the bottom of questionnaire click F11 on your keyboard and the

selection of buttons will be visible. If not please contact us at: [email protected].

Q10: When I enter the Portal I receive pop-up message as shown below. What shall I do?

A: This means that the questionnaire has expired and you are no longer able to complete and submit the

questionnaire. Contact the BD SBC Team for further instructions using the email address:

[email protected].





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Q11: Why should I answer question about product weight?

A: We ask you to provide the net weight of the item you supply to BD. This information together with

the information about the concentration of the substances in the item is needed to calculate total weight of

the substance per item. Units of measure we use are The International System of Units (SI) derived units

to make the questionnaire unified across the globe. If you use some other units of measure, please convert

them into SI derived units.

Documents

BD Supplier Materials of Concern Guidance