its an organization which check the quality and purity of food in india

1. LEGISLATION REGULATIONS OF FOOD
PRODUCTS WITH SPECIAL EMPHASIS ON BIS
PRESENTED BY:-
YOGESH KHATRI
1ST SEMESTER
M PHARM
UNDER THE GUIDENCE OF :-
AKKAMMA H . G
ASSISTANT PROF.
PH ANALYSIS
M PHARM

2. Introduction
• It is established by the Bureau of Indian Standards Act, 1986 which came into effect
on 23rd December 1986.The Minister in charge of the Ministry or Department having
administrative control of the BIS is the ex-officio President of the BIS.
• The organisation was formerly the Indian Standards Institution (ISI), set up under the
Resolution of the Department of Industries and Supplies No. 1 Std.(4)/45, dated 3
September 1946.
• The ISI was registered under the Societies Registration Act, 1860.
• As a corporate body, it has 25 members drawn from Central or State Governments,
industry, scientific and research institutions, and consumer organisations.
• Its headquarters are in New Delhi, with regional offices in Kolkata, Chennai,
Mumbai, Chandigarh and Delhi and 20 branch offices.

3. • PURPOSE :-
 The Indian Standards Institution gave the nation the standards it needed for
nationalization, orderly industrial and commercial growth, quality production and
competitive efficiency.
• However, in 1986 the government recognized the need for strengthening this
National Standards Body due to fast changing socio-economic scenario and
according it a statutory status.
• Thus came the Bureau of Indian Standards Act 1986 and on 1 April 1987, newly
formed BIS took over staff assets, liabilities and functions of erstwhile ISI.
• Through this change over, the Government envisaged building of the climate of
quality culture and consciousness and greater participation of consumers in
formulation and implementation of National Standard

4. OBJECTIVES:-
• Harmonious development of standardization, marking and quality certification
• To provide new thrust to standardization and quality control
• To evolve a national strategy for according recognition to standards and
integrating them with growth and development of production and exports
• To ensure branch offices work as focal point of the organization;
• Building brand image of BIS through enhanced publicity measures;

5. • Streamlining the functioning and modernization/ up-gradation of BIS
laboratories;
• Increasing productivity and efficiency of BIS laboratories;
• Building brand image of BIS through enhanced publicity measures;
• Web enabling of the Certification Marks Management System (CMMS);
• Streamlining the functioning and modernization/ up-gradation of BIS
laboratories;
• Increasing productivity and efficiency of BIS laboratories;

6. • Product Certification
• The Bureau of Indian Standards, empowered through an Act of the
Indian Parliament, known as the Bureau of Indian Standards Act,
1986, operates a product certification scheme by which it grants
licences to manufacturers covering practically every industrial
discipline from Agriculture to Textiles to Electronics.
• The certification allows the licensees to use the popular ISI Mark,
which has become synonymous with Quality products for the Indian
and neighbouring markets over the last more than 55 years.

7. OPERATING PRINCIPLE
• The BIS Product Certification Scheme operates as follow
• an impartial
• non discriminatory
• transparent manner.

8. • CERTIFICATION SYSTEM
• The BIS product certification scheme is essentially voluntary in
nature, and is largely based on ISO/IEC Guide 28 which provides
general rules for third party certification system of determining
conformity with product standards through initial testing and
assessment of a factory quality management system and its acceptance
followed by surveillance that takes into account the factory Quality
management system and the testing of samples from the factory and
the open market.
• All BIS certifications are carried out in accordance with Indian
Standards, which are amenable to certification. A large number of
operational elements of the BIS product certification scheme
correspond with the requirements of ISO/IEC 17065

9. • TYPES OF LICENSING
• Although, the scheme itself is voluntary in nature, the Government of
India, in public interest (for example public health and safety, security,
infrastructure requirements, mass consumption) has enforced
mandatory certification on various products through various Quality
Control Orders issued from time to time under various Acts.
• While BIS continues to grant licences on application, the enforcement
of compulsory certification is done by the authorities notified in such
quality control orders.
• For the list of items brought under mandatory certification, together
with the corresponding Indian Standard Number, and the authorities
responsible for enforcing the orders,

10. • Eligibility Criteria:
• The applicant must hold a BE/BTech in relevant disciplines or Masters
degree in Microbiology with minimum 60% aggregate scores.
• Age-Limit:
• The applicant must fall in the age bracket of 21-30 years.

11. • Bureau of Indian Standard Act, 1986( Functions of the Bureau).-
• (a) establish, publish and promote in such manner as may be prescribed the
Indian Standard in relation to any article to process;
• (b) recognise as an Indian Standard, in such manner as may be prescribed
any standard established by any other Institution in India or elsewhere, in
relation to any article or process;
• (c) specify a Standard Mark to be called the Bureau of Indian Standards
Certification Mark which shall be of such design and contain such particular
as may be prescribed to represent a particular Indian Standard;
• (d) grant, renew, suspend or cancel a licence for the use for the use Standard
Mark;

12. • (e) levy fees for the grant or renewal of any licence;
• (f) make such inspection and take such samples of any material or substance as
necessary to see whether any article or process in relation to which the Standard
Mark has been used conforms to the Indian Standard of whether the Standard
Mark has been improperly used in relation to any article or process with or
without a licence;
• (g) seek recognition of the Bureau and of the Indian Standards outside India on
such terms and conditions as may be mutually agreed upon by the Bureau with
any corresponding institution or organisation in any country;
• (h) establish, maintain and recognise laboratories for the purpose of
standardisation an quality control and for such other purpose as may be
prescribed;
• (i) undertake research for the formulation of Indian Standards in the interests of
consumers and manufacturers;

13. • (j) recognise any institution in India or outside which is engaged in the standardisation
of any process or the improvement of the quality of any article or process;
• (k) provide service to manufactured and consumers of articles or processes on such
terms and conditions as may be mutually agreed upon;
• (l) appoint agent in India or outside India for the inspection, testing and such other
purpose as may be prescribed;
• (m) established branches offices, or agencies in India or outside;
• (n) inspect any article or process at such times and at such places as may be
prescribed in relation to which the Standard Mark is used or which is required to
conform to the Indian Standard by this Actor under any other law irrespective of
whether such article or process is in India or is brought or intended to be brought into
India form a place outside India;

14. • (o) co-ordinate activities of any manufacturer or association of
manufacturers or consumers engaged in standardisation and in the
improvement of the quality of any article or process or in the
implementation or any quality control activities;
• (p) perform such other function as may be prescribed.
• (2) The Bureau shall perform its functions under this section in
accordance with, and subject to such rules as may be made by the
Central Government

15. • Scheme for Testing and Inspection
• The Scheme of Testing and Inspection ( STI ) is a document which specifies the control over
production process which the firm is required to exercise for operating the certification marks
licence.
• This is prepared by BIS in consultation with the first applicant for the product. For subsequent
applications, the applicability of the available STI is reviewed and changes made if necessary.
• The STI contains, inter alia the following provisions:
• a) Markings to be applied on the product and the method of applying the Standard Mark
• b) Definition of control unit

16. • c) The levels of control to be applied
• d) acceptance criteria, control unit wise
• e) Frequency of sampling and tests on raw materials, in
process materials and finished products
• g) Directions to licensees in event of quality related
problems
• h) A clause requiring free replacement of goods in case a
complaint is established bonafid

17. THE BUREAU OF INDIAN STANDARDS (CERTIFICATION) REGULATIONS, 1988
• In exercise of the powers conferred by section 38 of the Bureau of Indian Standards Act,
1986 (63 of 1986), the Executive Committee of the Bureau of Indian Standards, with the
previous approval of the Central Government, hereby makes the following regulations,
namely:
• 1. Short Title and Commencement - (1) These regulations may be called the Bureau of
Indian Standards (Certification) Regulations, 1988.
• (2) They shall come into force on the date of their publication in the Official Gazette.
• 2. Definitions - In these regulations, unless the context otherwise requires -
• 1. "Act" means the Bureau of Indian Standards Act, 1986 (63 of 1986);
• 2. "Form" means a form annexed to these regulations

18. MANNER, CONDITION, RATES OF FEE FOR GRANT AND RENEWAL
OF LICENCE (EXCEPT FOR MANAGEMENT SYSTEMS)
• Manner of Applying for Licence - (1) Every application for the grant of a licence
shall be made to the Bureau in ## Form-I.
• (2) Every application for a licence shall be accompanied by a statement furnishing
in detail any scheme of inspection and testing, which the applicant maintains or
has been in use or proposes to maintain or to put into use and which is designed to
regulate, during the course of manufacture or production, the quality of the article
or process for which the licence is applied for.
• (3) Every application shall be signed in the case of an individual, by the applicant
or, in the case of a firm, by the proprietor, partner or the managing director of the
firm or by any other person authorised to sign any declaration on behalf of the
firm. The name and designation of the person signing the application shall be
recorded legibly in the space set apart for the purpose in the application form

19. • 4) Every application for a licence shall, on receipt by the Bureau, be numbered in
order of priority of the receipt and be acknowledged.
• (5) The Bureau may call for any supplementary information or documentary
evidence from any applicant in support of or to substantiate any statement made by
him in his application, within such time as may be directed by the Bureau, and non-
compliance with such direction may have the effect of the application being
summarily rejected by the Bureau.
• (6) On receipt of an application for a licence and before granting a licence, the
Bureau may -
• a) require evidence to be produced that the article or process in respect of which a
licence has been applied for conforms to the related Indian Standard;
• b) require evidence to be produced that the applicant has in operation a scheme of
routine inspection and testing, which will adequately ensure that all marked products
shall conform to the Indian Standard

20. • 4. Grant of Licence - (1) If the Bureau, after a preliminary inquiry, is satisfied
that the applicant *having regard to requisite skill, equipment, systems,
resources, previous performance and antecedents relevant to the issuance of the
licence is fit to use the Standard Mark, the Bureau shall grant a licence in Form
II authorising the use of the Standard Mark in respect of the article or class of
articles manufactured by the applicant or in respect of the process employed in
any manufacture or work, subject to such terms and conditions as specified in
these regulations.
• The Bureau shall intimate the applicant about grant of licence.
• *(1A) Where the application for a licence is made by a person, who has been
convicted under section 33 of the Act, he shall not be eligible to apply for a
period of six months from the date of such conviction. The period of
disqualification shall be determined by the Bureau having regard to the facts
and circumstances of each case and it shall not exceed a period of one year

21. • (2) A licence shall be granted in Form II for a period of one year in the first instance. The
Bureau may, on an application made by a licensee at least one month before the expiry of
the period for which the licence has been granted, renew the same for a like period. Renewal
of the licence for subsequent period may also be done by the Bureau in a similar manner:
• Provided that if the Bureau so decides, depending, among other things, on the licensee's
performance, it may renew the licence for a period longer than one year but not exceeding
two years at a time.
• (3) The Bureau may, during the period of the validity of the licence, alter by giving one
month's notice to a licensee any terms and conditions subject to which the licence has been
granted.
• (4) Where the Bureau, after a preliminary inquiry, is of the opinion that a licence should not
be granted, the Bureau shall give a reasonable opportunity to the applicant of being heard,
either in person or through a representative authorised by him in this behalf, and may take
into consideration any fact or explanation urged on behalf of the applicant before rejecting
the application.

22. • (5) Where a licence to use Standard Mark has been granted, it shall be notified
in the Official Gazette specifying the particulars of the licence.
• (6) A licence, unless renewed or its renewal is deferred by the Bureau shall
expire at the end of the period for which it is granted.
• (7) Particulars of all licences issued by the Bureau under these regulations in
connection with the use of Standard Mark shall be entered in a register which
the Bureau shall maintain.

23. • Powers of the Bureau - The Bureau may at its discretion under the provisions of section
15 of the Act, -
• (a) Refuse to grant or renew a licence or extend its scope or cancel or alter so as to reduce
the scope of the licence provided that the refusal for grant, renewal, cancellation or
alteration is a recommendation of the assessment team to which a decision by the Director
General of the Bureau shall be conclusive.
• The refusal to renew or cancel a licence for failure to discharge the obligations under
item-M, shall be based on the report of assessment/audit during surveillance and regular
review or reassessment. Such decisions shall be communicated to the applicant or licensee
in writing.
• (b) Any authorized officer of the Bureau shall be entitled to suspend a licence if there are
sufficient grounds of non-compliance of the following, -
• (i) if surveillance proves non-conformity to the relevant requirements but immediate
termination is not considered necessary;
• (ii) if improper use of the licence is made

24. • ii) if related documents are not corrected to the Bureau's satisfaction;
• (iv) if there has been any contravention of procedures set out by the Bureau;
• (v) if the licensee fails to meet financial obligations to the Bureau; and
• (vi) on any other grounds specifically provided for under the procedures,
rules or formally agreed between the licensee and the Bureau.
• (c) The Bureau may revoke suspension of a licence after satisfying itself that
the licensee has taken necessary actions to remove the deficiencies within
time limits specified by the Bureau.
• (d) Before the Bureau suspends or cancels any licence, it shall give the
licensee not less than fourteen days notice of its intention to suspend or
cancel the licence

25. REFERENCE
• www.google.com
• www.slideshare.com